Atlas FDA

GAG

43 FDA 510(k) clearances · Product code

61 daysmedian time to decision
214 days90th percentile
43clearances measured

FDA profile

Official device name
Stapler, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4740
Medical specialty
General Hospital
FDA definition
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Adverse events (MAUDE)
2021: 53 · 2022: 50 · 2023: 109 · 2024: 1,126 · 2025: 1,082 · 2026: 849
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) (K253527)Covidien, LLC2026-07-01
AEON™ Endoscopic Powered Stapler (K251482)Lexington Medical, Inc.2025-07-11
da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (K243596)Intuitive Surgical, Inc.2025-03-10
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) (K240881)Covidien (Part of Medtronic)2024-11-01
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) (K241629)Ethicon Endo-Surgery, LLC2024-07-03
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) (K234039)Lexington Medical, Inc.2024-05-07
GIA™ Stapler with Tri-Staple™ Technology (K231934)Covidien2023-10-27
TA™ Stapler and Loading Unit with DST Series™ Technology (K231491)Covidien2023-08-16
EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil (K232126)Covidien2023-08-16
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (K221629)Covidien2023-02-22
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (K213633)Ethicon Endo-Surgery, LLC2022-04-08
PROXIMATE DISPOSABLE SKIN STAPLER (K970079)Ethicon Endo-Surgery, Inc.1997-03-11
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP (K962258)Ethicon Endo-Surgery, Inc.1996-09-11
DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES (K934105)Surgical Innovations Corp.1994-03-28
DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART (K934188)Deroyal Industries, Inc.1994-03-28
PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER (K932476)Ethicon Endo-Surgery, Inc.1993-12-01
REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) (K933901)Richard-Allan Medical1993-11-19
SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM (K926127)Life Medical Sciences, Inc.1993-06-24
PROXIMATE LINEAR CUTTER THICK TISSUE INST. (K892927)ETHICON, Inc.1989-05-26
HERNIASTAT (K884404)Innovative Surgical Devices Corp.1988-11-08
V. MUELLER (R) GOOSENECK CIRCULAR STAPLER (K862772)American V. Mueller1986-08-18
WECK LX TM SKIN STAPLER (K851258)Edward Weck, Inc.1985-06-07
PI-PHEUMO INTESTINAL INSTRUMENT SET (K851121)Surgeons Choice, Inc.1985-04-25
V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS (K850947)American V. Mueller1985-04-17
APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE (K844417)Davis & Geck, Inc.1984-12-17
V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET (K844628)American V. Mueller1984-12-14
APPOSE ULE STERILE DISPOS. SKIN STAP (K840177)Davis & Geck, Inc.1984-03-05
APPOSE DISPOS. SKIN STAPLER W/AUTO (K840178)Davis & Geck, Inc.1984-03-05
HYPO SUTURE (K834138)Medical Design & Manufacturing Corp.1984-01-27
PARAMETRIC STERILITY RELEASE OF AUTO (K830741)United Surgical Corp.1983-08-11
PI-PNEUMO-INTESTINAL INSTRUMENT SET (K823776)Surgeons Choice, Inc.1983-01-14
PROXIMATE DISPOSABLE SKIN STAPLERS (K820811)ETHICON, Inc.1982-08-20
DEKNATEL SKIN STAPLE EXTRACTOR (K821228)Howmedica Corp.1982-05-14
ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER (K813170)Surgeons Choice, Inc.1982-02-12
APPOSE SKIN STAPLER (K811030)Davis & Geck, Inc.1981-05-27
PROXIMATE*II DISPOSABLE SKIN STAPLER (K803038)ETHICON, Inc.1980-12-30
AUTO SUTURE DISPOS., EEA SURG. STAPLER (K802611)U. S. Surgical Corp.1980-11-12
SKIN STAPLER HANDLE 523700/CARTRIDGES (K801445)Edward Weck, Inc.1980-07-14
PROXIMATE DISP. SKIN STAPLER (K771619)ETHICON, Inc.1977-11-15
SURGICAL STAPLING INSTRU., AUTO, SUTURE (K771177)United States Surgical, A Division of Tyco Healthc1977-10-18
AUTO SUTURE R CLIP INSTRUMENT (K771113)United States Surgical, A Division of Tyco Healthc1977-09-30
SKIN STAPLING INSTRUMENT (K760732)ETHICON, Inc.1976-11-03
SKIN STAPLE EXTRACTOR (K760733)ETHICON, Inc.1976-11-03

Track GAG automatically

Every clearance here is in the API, with alerts when new ones post.