KGS

20 FDA 510(k) clearances · Product code

44 daysmedian time to decision

335 days90th percentile

20clearances measured

FDA profile

Official device name: Retention Device, Suture
Device class: Class I (low risk)
Regulation: 21 CFR 878.4930
Medical specialty: General, Plastic Surgery
Adverse events (MAUDE): 2005: 14 · 2006: 19 · 2007: 26 · 2008: 15 · 2009: 6 · 2013: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Record	Firm	Date
SOFT TISSUE ANCHORING WASHERS (K030031)	Accu-Speed, Incorporated	2003-01-28
RBM (K020480)	Smith & Nephew, Inc.	2002-03-12
SUTURE LOCK (K964935)	Smith & Nephew Endoscopy, Inc.	1997-02-25
ACUFEX ROTATOR CUFF FIXATION BUTTON (K941740)	Acufex Microsurgical, Inc.	1995-06-30
MITEK CONE WASHER (K930675)	Mitek Surgical Products, Inc.	1993-11-09
VENTROFIL TENSION RELIEF SUTURE SET (K904435)	Aesculap, Inc.	1991-08-29
TRAY DOUGH (K911225)	The Hygenic Corp.	1991-04-17
SUTURE TENSION ADJUSTMENT REEL (K904136)	Surgical Systems, Inc.	1990-10-02
SURGICAL RETENTION BAR (K902001)	Acufex Microsurgical, Inc.	1990-05-09
ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE (K896310)	Acufex Microsurgical, Inc.	1989-11-20
DERMACARE TIE HOLDER (K893995)	Dermacare	1989-08-11
ACUFEX FIXATION BUTTON (K884565)	Acufex Microsurgical, Inc.	1989-02-27
SUTURE RETENTION DEVICE (K883299)	Edwards Orthopaedics Div., Baxter Healthcare Corp.	1988-08-23
HEWSON A.C.L. GUIDE SET (K872608)	Concept, Inc.	1987-09-16
LE VEEN WOUND SPLINT (K863570)	Tek-Aid, Inc.	1986-09-29
BIOMER * PLEDGET SUTURE BUTTRESS (K832138)	ETHICON, Inc.	1984-05-23
CRUCIATE LIGAMENT BUTTON (K813581)	Biomet, Inc.	1982-03-23
ETHICON* SURGICAL SUTURES W/COMPRESS BOL (K812819)	ETHICON, Inc.	1981-11-20
HEWSON LIGAMENT BUTTON (K792004)	Richard'S Medical Equip., Inc.	1979-11-05
SUTURE RETENTION CLAMP (K771554)	Concept, Inc.	1977-09-02

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