GAG

AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)

Advisory panel: General Hospital
Total cleared: 42

Adverse events under product code GAG

product code GAG

Death: 23
Injury: 394
Malfunction: 2,304
Other: 6
Total: 2,727

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 GAG

K251482 — AEON Endoscopic Powered Stapler Lexington Medical, Inc. · 2025-07-11
K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) Intuitive Surgical, Inc. · 2025-03-10
K240881 — Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) Covidien (Part of Medtronic) · 2024-11-01
K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) Ethicon Endo-Surgery, LLC · 2024-07-03
K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) Lexington Medical, Inc. · 2024-05-07
K231934 — GIA Stapler with Tri-Staple Technology Covidien · 2023-10-27
K231491 — TA Stapler and Loading Unit with DST Series Technology Covidien · 2023-08-16
K232126 — EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil Covidien · 2023-08-16
K221629 — Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) Covidien · 2023-02-22
K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler Ethicon Endo-Surgery, LLC · 2022-04-08
K970079 — PROXIMATE DISPOSABLE SKIN STAPLER Ethicon Endo-Surgery, Inc. · 1997-03-11
K962258 — ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP Ethicon Endo-Surgery, Inc. · 1996-09-11
K934105 — DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES Surgical Innovations Corp. · 1994-03-28
K934188 — DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART Deroyal Industries, Inc. · 1994-03-28
K932476 — PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER Ethicon Endo-Surgery, Inc. · 1993-12-01
K933901 — REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) Richard-Allan Medical · 1993-11-19
K926127 — SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM Life Medical Sciences, Inc. · 1993-06-24
K892927 — PROXIMATE LINEAR CUTTER THICK TISSUE INST. ETHICON, Inc. · 1989-05-26
K884404 — HERNIASTAT Innovative Surgical Devices Corp. · 1988-11-08
K862772 — V. MUELLER (R) GOOSENECK CIRCULAR STAPLER American V. Mueller · 1986-08-18
K851258 — WECK LX TM SKIN STAPLER Edward Weck, Inc. · 1985-06-07
K851121 — PI-PHEUMO INTESTINAL INSTRUMENT SET Surgeons Choice, Inc. · 1985-04-25
K850947 — V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS American V. Mueller · 1985-04-17
K844417 — APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE Davis & Geck, Inc. · 1984-12-17
K844628 — V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET American V. Mueller · 1984-12-14
K840177 — APPOSE ULE STERILE DISPOS. SKIN STAP Davis & Geck, Inc. · 1984-03-05
K840178 — APPOSE DISPOS. SKIN STAPLER W/AUTO Davis & Geck, Inc. · 1984-03-05
K834138 — HYPO SUTURE Medical Design & Manufacturing Corp. · 1984-01-27
K830741 — PARAMETRIC STERILITY RELEASE OF AUTO United Surgical Corp. · 1983-08-11
K823776 — PI-PNEUMO-INTESTINAL INSTRUMENT SET Surgeons Choice, Inc. · 1983-01-14
K820811 — PROXIMATE DISPOSABLE SKIN STAPLERS ETHICON, Inc. · 1982-08-20
K821228 — DEKNATEL SKIN STAPLE EXTRACTOR Howmedica Corp. · 1982-05-14
K813170 — ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER Surgeons Choice, Inc. · 1982-02-12
K811030 — APPOSE SKIN STAPLER Davis & Geck, Inc. · 1981-05-27
K803038 — PROXIMATE*II DISPOSABLE SKIN STAPLER ETHICON, Inc. · 1980-12-30
K802611 — AUTO SUTURE DISPOS., EEA SURG. STAPLER U. S. Surgical Corp. · 1980-11-12
K801445 — SKIN STAPLER HANDLE 523700/CARTRIDGES Edward Weck, Inc. · 1980-07-14
K771619 — PROXIMATE DISP. SKIN STAPLER ETHICON, Inc. · 1977-11-15
K771177 — SURGICAL STAPLING INSTRU., AUTO, SUTURE United States Surgical, A Division of Tyco Healthc · 1977-10-18
K771113 — AUTO SUTURE R CLIP INSTRUMENT United States Surgical, A Division of Tyco Healthc · 1977-09-30
K760732 — SKIN STAPLING INSTRUMENT ETHICON, Inc. · 1976-11-03
K760733 — SKIN STAPLE EXTRACTOR ETHICON, Inc. · 1976-11-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.