Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GAG — Predicate Candidate Screening
43 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
214 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGC | Covidien, LLC | 2026-07-01 | 230 | 0 |
| K251482 | AEON™ Endoscopic Powered Stapler | Lexington Medical, Inc. | 2025-07-11 | 58 | 0 |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | 2025-03-10 | 109 | 0 |
| K240881 | Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Sig | Covidien (Part of Medtronic) | 2024-11-01 | 214 | 0 |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45m | Ethicon Endo-Surgery, LLC | 2024-07-03 | 27 | 0 |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endosc | Lexington Medical, Inc. | 2024-05-07 | 138 | 0 |
| K231934 | GIA™ Stapler with Tri-Staple™ Technology | Covidien | 2023-10-27 | 119 | 0 |
| K231491 | TA™ Stapler and Loading Unit with DST Series™ Technology | Covidien | 2023-08-16 | 85 | 0 |
| K232126 | EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ | Covidien | 2023-08-16 | 30 | 0 |
| K221629 | Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ | Covidien | 2023-02-22 | 261 | 0 |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | Ethicon Endo-Surgery, LLC | 2022-04-08 | 142 | 0 |
| K970079 | PROXIMATE DISPOSABLE SKIN STAPLER | Ethicon Endo-Surgery, Inc. | 1997-03-11 | 61 | 0 |
| K962258 | ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CAR | Ethicon Endo-Surgery, Inc. | 1996-09-11 | 91 | 0 |
| K934105 | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | Surgical Innovations Corp. | 1994-03-28 | 217 | 0 |
| K934188 | DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART | Deroyal Industries, Inc. | 1994-03-28 | 214 | 0 |
| K932476 | PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER | Ethicon Endo-Surgery, Inc. | 1993-12-01 | 191 | 0 |
| K933901 | REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) | Richard-Allan Medical | 1993-11-19 | 101 | 0 |
| K926127 | SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM | Life Medical Sciences, Inc. | 1993-06-24 | 202 | 0 |
| K892927 | PROXIMATE LINEAR CUTTER THICK TISSUE INST. | ETHICON, Inc. | 1989-05-26 | 35 | 0 |
| K884404 | HERNIASTAT | Innovative Surgical Devices Corp. | 1988-11-08 | 20 | 0 |
| K862772 | V. MUELLER (R) GOOSENECK CIRCULAR STAPLER | American V. Mueller | 1986-08-18 | 27 | 0 |
| K851258 | WECK LX TM SKIN STAPLER | Edward Weck, Inc. | 1985-06-07 | 71 | 0 |
| K851121 | PI-PHEUMO INTESTINAL INSTRUMENT SET | Surgeons Choice, Inc. | 1985-04-25 | 37 | 0 |
| K850947 | V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS | American V. Mueller | 1985-04-17 | 41 | 0 |
| K844417 | APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE | Davis & Geck, Inc. | 1984-12-17 | 32 | 0 |
| K844628 | V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET | American V. Mueller | 1984-12-14 | 17 | 0 |
| K840177 | APPOSE ULE STERILE DISPOS. SKIN STAP | Davis & Geck, Inc. | 1984-03-05 | 48 | 0 |
| K840178 | APPOSE DISPOS. SKIN STAPLER W/AUTO | Davis & Geck, Inc. | 1984-03-05 | 48 | 0 |
| K834138 | HYPO SUTURE | Medical Design & Manufacturing Corp. | 1984-01-27 | 58 | 0 |
| K830741 | PARAMETRIC STERILITY RELEASE OF AUTO | United Surgical Corp. | 1983-08-11 | 156 | 0 |
| K823776 | PI-PNEUMO-INTESTINAL INSTRUMENT SET | Surgeons Choice, Inc. | 1983-01-14 | 30 | 0 |
| K820811 | PROXIMATE DISPOSABLE SKIN STAPLERS | ETHICON, Inc. | 1982-08-20 | 150 | 0 |
| K821228 | DEKNATEL SKIN STAPLE EXTRACTOR | Howmedica Corp. | 1982-05-14 | 17 | 0 |
| K813170 | ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER | Surgeons Choice, Inc. | 1982-02-12 | 87 | 0 |
| K811030 | APPOSE SKIN STAPLER | Davis & Geck, Inc. | 1981-05-27 | 41 | 0 |
| K803038 | PROXIMATE*II DISPOSABLE SKIN STAPLER | ETHICON, Inc. | 1980-12-30 | 29 | 0 |
| K802611 | AUTO SUTURE DISPOS., EEA SURG. STAPLER | U. S. Surgical Corp. | 1980-11-12 | 22 | 0 |
| K801445 | SKIN STAPLER HANDLE 523700/CARTRIDGES | Edward Weck, Inc. | 1980-07-14 | 24 | 0 |
| K771619 | PROXIMATE DISP. SKIN STAPLER | ETHICON, Inc. | 1977-11-15 | 83 | 0 |
| K771177 | SURGICAL STAPLING INSTRU., AUTO, SUTURE | United States Surgical, A Division of Tyco Healthc | 1977-10-18 | 110 | 0 |
| K771113 | AUTO SUTURE R CLIP INSTRUMENT | United States Surgical, A Division of Tyco Healthc | 1977-09-30 | 101 | 0 |
| K760732 | SKIN STAPLING INSTRUMENT | ETHICON, Inc. | 1976-11-03 | 36 | 0 |
| K760733 | SKIN STAPLE EXTRACTOR | ETHICON, Inc. | 1976-11-03 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda