Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GDW — Predicate Candidate Screening

283 FDA 510(k) clearances under this product code; the 50 most recent screened below.

71 daysmedian FDA review time

196 days90th percentile

283clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260196	ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapl	Ethicon Endo-Surgery, LLC	2026-05-11	109	0
K253657	Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™	Covidien (Part of Medtronic)	2026-04-10	141	0
K252739	ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000	Ethicon Endo-Surgery, LLC	2025-12-17	111	0
K250835	ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60	Ethicon Endo-Surgery, LLC	2025-05-14	55	0
K243276	ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR	Ethicon Endo-Surgery, LLC	2025-02-25	132	0
K241630	ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60	Ethicon Endo-Surgery, LLC	2024-10-28	144	0
K242679	Disposable Powered Articulating Endoscopic Linear Cutter Sta	Fengh Medical Co., Ltd.	2024-10-04	28	0
K222487	Anika Tissue Tack Fixation System	Anika Therapeutics, Inc.	2023-05-08	264	0
K222210	AEON Endoscopic Stapler	Lexington Medical, Inc.	2023-04-21	270	0
K223760	ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cu	Ethicon Endo-Surgery	2023-03-15	90	1
K211197	Disposable Endoscopic Cutter Stapler and Cartridge	Changzhou Waston Medical Appliance Co., Ltd.	2023-01-19	638	0
K221771	EEA Circular Stapler with Tri-Staple Technology	Covidien	2022-11-30	162	0
K222641	Signia™ Small Diameter Reloads Including Regular (Round) Tip	Covidien	2022-11-29	89	1
K221003	Autosuture EEA Stapler / circular stapler with DST Series Te	Covidien	2022-09-30	178	0
K221013	GIA Auto Suture Stapler with DST Series Technology	Covidien	2022-05-05	30	0
K221005	EEA Circular Stapler with Tri-Staple Technology	Covidien	2022-04-29	24	0
K221006	GIA Stapler with Tri-Staple Technology	Covidien	2022-04-29	24	0
K211811	Disposable Endoscopic Staplers and Reload Unit, Disposable H	Wuxi Beien Surgery Device Co., Ltd.	2022-03-03	265	0
K211458	Disposable Anorectal Staplers, Disposable Intraluminal Stapl	Ningbo Verykind Medical Device Co., Ltd.	2021-12-30	233	0
K201934	Surgimatix Absorbable Fixation System	Surgimatix, Inc.	2021-10-01	445	0
K210909	easyEndo Lite Linear Cutting Stapler and Loading Unit for Si	Ezisurg Medical Co., Ltd.	2021-06-24	87	0
K201639	Disposable Circular Staple, Disposable Hemorrhoidal Stapler,	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	2021-05-27	345	0
K202709	Disposable Powered Endoscopic Linear Cutting Staplers and Ca	Ningbo Verykind Medical Device Co., Ltd.	2021-05-18	244	0
K210278	Titan SGS	Standard Bariatrics	2021-04-28	86	0
K200320	Mirus Circular Stapler, Mirus Linear Cutter and Reload, Miru	M/s. Meril Endo Surgery Private Limited.	2021-02-05	364	0
K202507	EEA Circular Stapler with Tri-Staple Technology	Covidien	2021-01-21	143	0
K203117	TissueTak device	Via Surgical , Ltd.	2021-01-07	83	0
K202467	Disposable Powered Articulating Endoscopic Linear Cutter Sta	Fengh Medical Co., Ltd.	2020-12-14	109	0
K202701	GIA Stapler with Tri-Staple Technology	Covidien	2020-12-07	82	0
K202864	Tri-Staple 2.0 Reloads	Covidien	2020-10-28	30	0
K202665	Echelon Flex 45mm Powered Plus Articulating Endoscopic Linea	Ethicon Endo-Surgery, LLC	2020-10-15	31	0
K201882	AEON Endoscopic Stapler	Lexington Medical, Inc.	2020-10-09	93	0
K201280	Ethicon Circular Stapler, Ethicon Circular Stapler -XL Seale	Ethicon Endo-Surgery, LLC	2020-07-27	75	0
K201672	Signia Stapler (with new software)	Covidien	2020-07-17	28	0
K200420	Echelon Contour Curved Cutter with blue reload, Echelon Cont	Ethicon Endo-Surgery, LLC	2020-06-29	130	0
K192720	GIA Stapler with Tri-Staple Technology	Covidien	2020-03-13	168	0
K192330	EEA Circular Stapler with Tri-Staple Technology	Covidien	2020-01-23	149	0
K190884	TigerPaw Pro Left Atrial Appendage Occlusion Fastener And De	Datascope Corp.	2019-12-26	266	0
K182476	Disposable Powered Articulating Endoscopic Linear Cutter Sta	Fengh Medical Co., Ltd.	2019-12-18	464	0
K190331	Applied Medical Laparoscopic Linear Cutter	Applied Medical Resources Corporation	2019-11-22	281	0
K192566	Reach and CQ'ENCE Circular Staplers	Reach Surgical, Inc.	2019-10-17	29	0
K191070	Signia Small Diameter Reloads	Covidien	2019-09-04	135	4
K191287	OptiFix AT Absorbable Fixation System with Articulating Tech	Davol Inc., Subsidiary of C.R. Bard	2019-07-16	64	0
K182217	Linear Cutter Staplers and Loading Units for Single Use, Cir	Ezisurg (Suzhou) Medical Co., Ltd.	2019-04-16	244	0
K182475	Signia Circular Adapters (for use with Signia Staplers), Tri	Covidien	2019-03-14	185	0
K181668	FasTouch Absorbable Fixation System	Via Surgical , Ltd.	2019-03-13	261	0
K183477	easyPPHTM Hemorrhoidal Stapler for Single Use	Ezisurg Medical Co., Ltd.	2019-02-11	56	0
K183435	Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold,	Ethicon Endo-Surgery, LLC	2019-02-06	57	0
K181657	easyLCTM Linear Cutter Staplers and Loading Units fot Single	Ezisurg Medical Co., Ltd.	2019-02-01	224	0
K180175	SignalMark Lung Biopsy Site Marker	View Point Medical, Inc.	2018-12-07	319	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