GDO

14 FDA 510(k) clearances · Product code

29 daysmedian time to decision

119 days90th percentile

14clearances measured

FDA profile

Official device name: Applier, Surgical, Clip
Device class: Class I (low risk)
Regulation: 21 CFR 878.4800
Medical specialty: General, Plastic Surgery
Adverse events (MAUDE): 2021: 304 · 2022: 361 · 2023: 365 · 2024: 287 · 2025: 548 · 2026: 484
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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Record	Firm	Date
UNICLIP SURGICAL CLIP APPLIER (K926199)	Unisurge, Inc.	1993-04-20
MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP (K890941)	United States Surgical, A Division of Tyco Healthc	1989-04-07
TOWEL CLIPS (K890159)	Dhason Brothers, Inc.	1989-02-03
SUTURE CLIP APPLIER/REMOVER (K890233)	Kinetic Medical Products	1989-01-27
DISPOSABLE MULTIPLE LIGATING CLIP (K820837)	ETHICON, Inc.	1982-05-28
ETHICON MULTIPLE LIGATING CLIP APPLIER (K812291)	ETHICON, Inc.	1981-09-11
HEMOSPENSER CARTRIDGE CAT. NO. 523500- (K792378)	Edward Weck, Inc.	1979-12-06
BAYONET HEIFETZ CLIP APPLIERS (K791845)	Edward Weck, Inc.	1979-10-17
SURGICAL DRAPE CLIP #201 (K790855)	C. Intl.	1979-08-03
360 HEMOCLIP APPLIERS (K791157)	Edward Weck, Inc.	1979-06-27
REYNOLDS DOUBLE HEMOCLIP APPLIERS (K790990)	Edward Weck, Inc.	1979-06-05
FORCEPS, SUTURE, AUTO (K772286)	Hartmann Group, Inc.	1977-12-20
LIGACLIP MULTIPLE CLIP APPLIER (K771412)	ETHICON, Inc.	1977-11-28
SUTURE CLIP REMOVER (K771640)	United States Surgical, A Division of Tyco Healthc	1977-09-30

Track GDO automatically

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