FED
Single-use Ureteral Access Sheath
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 100
Adverse events under product code FED
product code FED- Death
- 10
- Total
- 10
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 FED
- K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
- K252572 — Prodeon Urethral Sheath System
- K250128 — Single Use Suction-Evacuation Ureteral Access Sheath
- K250132 — Ureteral Access Sheath
- K250695 — Single-use Ureteral Access Sheath
- K251599 — Single-use Ureteral Access Sheath
- K250585 — LumenaTM Ureteral Access Sheath
- K250452 — CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
- K243710 — Disposable ureteral access sheath
- K250517 — Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006
- K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
- K243025 — Ureteral Access Sheath
- K242173 — Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
- K243091 — Over-tube (TR-1108A)
- K240167 — Single-use Ureteral Access Sheath
- K241181 — Disposable Ureteral Guide Sheath
- K240853 — Pathfinder® CR System
- K233472 — CVAC Aspiration System + CVAC Image Processor
- K230752 — Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
- K230748 — Disposable Ureteral Access Sheath
- K230801 — Pathfinder Endoscope Overtube with Balloon Device
- K220065 — Single Use Ureteral Access Sheath
- K200770 — Mini PCNL-System
- K211301 — Pathfinder Endoscope Overtube
- K203165 — Disposable Ureteral Access Sheath
- K203119 — ClearPetra Suction-Evacuation Sheath
- K201815 — Dornier MAGELLAN Ureteral Access Sheath
- K200419 — Kalera Vacuum Aspiration Catheter (K-VAC)
- K192691 — PatCom Single-Use Introducer
- K191415 — Pathfinder Endoscope Overtube
- K191067 — Arc Endocuff Glide AEG110 & AEG120
- K182403 — Peel-Away Introducer
- K182520 — Flexible Overtube
- K190030 — Embrella Endoscopic Distal Attachment
- K181811 — ReTrace Ureteral Access Sheath
- K173400 — ORISE Tissue Retractor System
- K171208 — Trans-anal Introducer
- K172575 — BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
- K172217 — Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
- K162205 — Arc EndoCuff and Arc EndoCuff Vision
- K161110 — ClearPetra Suction-Evacuation Sheath
- K160846 — AmplifEYE
- K160861 — Proxis Ureteral Access Sheath
- K151084 — Well Lead Ureteral Access Sheath
- K151801 — Arc Endocuff Vision
- K150083 — Sidecar External Working Channel
- K140523 — RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
- K140323 — NAVIGATOR HD URETERAL ACCESS SHEATH SETS
- K131598 — ANAL RECTAL OVERTUBE
- K133359 — ENDORINGS
- K123013 — ENDOSCOPIC INTRODUCER
- K123675 — RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
- K122649 — NAVIGATOR HD URETERAL ACCESS SHEATH SET
- K122270 — OVERTUBE ENDOSCOPIC ACCESS SYSTEM
- K120126 — BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
- K122565 — ARC ENDOCUFF
- K110531 — ENDOFLIP ECD
- K102485 — RE-TRACE URETERAL ACCESS SHEATH
- K082102 — GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
- K100081 — ENTEROSCOPY OVERTUBE, MODEL 00712140
- K092221 — COLONIC SPLINTING OVERTUBE, MODEL 00711145
- K092156 — CAD 12, COLONOSCOPY ASSIST DEVICE
- K091773 — FUJINON STERILE OVERTUBES
- K082589 — BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
- K080050 — SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
- K072405 — USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
- K062805 — MODIFICATION TO ENDO-EASE
- K061324 — EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
- K061216 — USGI TRANSPORT ENDOSCOPIC GUIDE
- K052084 — ENDO-EASE ENDOSCOPIC OVERTUBE
- K051919 — MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
- K051504 — SPYSCOPE ACCESS AND DELIVERY CATHETER
- K043418 — COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
- K050253 — USGI SHAPELOCK ENDOSCOPIC GUIDE
- K040836 — DISPOSABLE OVERTUBE
- K033954 — SHAPE LOCKING ENDOSCOPIC OVERTUBE
- K033778 — MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
- K023902 — SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
- K030642 — DEFLECTING URETERAL ACCESS SHEATH
- K030956 — NAVIGATOR URETERAL ACCESS SHEATH SET
- K030438 — BARD AQUAGUIDE URETERAL CONDUIT
- K022686 — LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
- K002018 — NDO SURGICAL SURGICAL OVERTUBE
- K993650 — URETERAL ACCESS SHEATH SET - NEW MODELS
- K990775 — URETERAL ACCESS SHEATH SET
- K983415 — DELIVERY SHEATH
- K973500 — BARD ENDOSCOPIC OVERTUBE (#000307)
- K972781 — OT-1
- K942573 — COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
- K942044 — BARD ENDOSCOPIC OVERTUBE
- K921120 — FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER
- K912265 — MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
- K903842 — ST-E1 OVERTUBE
- K896680 — PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
- K890629 — ESOPHAGEAL OVERTUBE
- K841258 — FOREIGN BODY PROTECTOR
- K833268 — ENDOSCOPIC OVERTUBE
- K830247 — SPLIT COLON STIFFENING TUBE
- K813325 — KEY MED FOREIGN BODY REMOVAL TUBE
- K810180 — WILLIAMS OESOPHAGEAL VARICES INJECT TUBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.