GCJ
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1,414
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GCJ
1–100 of 1,414- K260089 — TL-10 Laparoscopic Scope Cleaner
- K260197 — Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
- K252714 — C-Lant Port
- K253978 — Universal Seal (5-12 mm)
- K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
- K260177 — Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)
- K251923 — Medical Shaver System (Morcellator) (YSB-IIIA)
- K252957 — Pneumo Dissector Hook
- K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K250927 — KARL STORZ Cholangiography Set
- K242606 — Nuvis® Wireless HD Camera System (Nuvis-2K)
- K252442 — Kii Structural Balloon Access System
- K252697 — 3D Laparoscope
- K252640 — VereSee Optical Veres Needle and Endoscopic Camera
- K251994 — Arthrex Synergy Vision Imaging System
- K243968 — Revolve Surgical System
- K250551 — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
- K251743 — SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
- K250124 — Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)
- K250130 — Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)
- K252010 — SPY Laparoscope
- K250820 — Disposable Trocars
- K243399 — Boehringer Laboratories Liver Retractor
- K251490 — 8 mm Assist Cannula; 12 mm Assist Cannula
- K251209 — Medical Monitor (32HS710S)
- K250728 — Arthrex Synergy Vision Endoscopic Imaging System
- K243867 — LAGIS Suction Irrigation System
- K250411 — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
- K243439 — Medical Monitor (27HS714S)
- K243008 — Arthrex NanoScope System
- K243307 — LCD Monitor (MDEC-2523)
- K242927 — Suction Irrigation Tubing Set
- K240831 — MultiCut Solo
- K240334 — LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
- K242513 — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
- K241052 — Bladeless Trocar; Bladed Trocar; Hasson Trocar
- K241796 — TroCare TroKit Laparoscope Lens Wiper (CP000626)
- K241913 — da Vinci Handheld Camera
- K241401 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K241402 — Medical Monitor (32HR734S)
- K241530 — Stellar Imaging System
- K241360 — Universal Seal (5-12 mm)
- K241361 — Arthrex Synergy Vision Endoscopic Imaging System
- K241502 — P-SCOPE
- K241739 — Endoscopic Applicator, 41 cm
- K241111 — AMT Suture Passer
- K233840 — Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)
- K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
- K240196 — Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
- K233892 — 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
- K233386 — Monik - Disposable Endoscopic Trocar
- K240205 — Ez Catch Auto; Ez Catch YR; Ez Catch TR
- K233263 — Disposable Trocars
- K240635 — ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm
- K240174 — 1688 4K Camera System with Advanced Imaging Modality
- K233451 — Arthrex Synergy Vision Endoscopic Imaging System
- K222783 — MD Mattress Suture Placement Device
- K233327 — 1788 4K Camera System with Advanced Imaging Modality
- K232519 — ENDOCOLLECT Specimen Retrieval Bag
- K231066 — CuratOR EX3242-FD
- K232866 — Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
- K232880 — Inzii Ripstop Redeployable Retrieval System
- K232042 — NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021);
- K231725 — Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
- K231622 — REGER Nebulizer Irrigation Cannula
- K232701 — Guardenia (GAR-1)
- K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- K231400 — Bladeless Trocar Artemis Lap Cannula
- K231003 — Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
- K231358 — Universal Seal (5-12 mm)
- K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-
- K230886 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K231042 — Disposable Laparoscopic Trocar
- K223718 — HandX Self-Righting Needle Holder
- K223562 — Xpan Universal Trocar System
- K230491 — HandX Monopolar Scissors
- K230058 — Bladeless Trocar Artemis Lap Cannula
- K230605 — 1788 4K Camera System with Advanced Imaging Modality
- K223923 — HOPKINS Telescopes
- K223593 — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
- K222828 — Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
- K223116 — 8X-10-6XXX Camera Head
- K223759 — Arthrex SynergyID Endoscopic Imaging System
- K221591 — Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
- K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
- K221861 — FloNavi Endoscopic Fluorescence Imaging System
- K221781 — Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
- K213597 — MultiCut Solo
- K221252 — Scivita 4KINSIGHT ICG Imaging System
- K222011 — HandX Instrument - Monopolar Spatula
- K221004 — HOPKINS Telescopes
- K222575 — HurriChem Device Kit
- K212736 — Canady Flex RoboWrist
- K222504 — H1
- K221740 — SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
- K222890 — RADIANCE ULTRA 32 4K ZEROWIRE DUO
- K222079 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- K221533 — Plasma Shield
- K221365 — LapBox Tissue Containment Removal System
- K222130 — 1688 4K Camera System with Advanced Imaging Modality
Data sourced from openFDA. This site is unofficial and independent of the FDA.