KGS · Class I · 21 CFR 878.4930

FDA Product Code KGS: Retention Device, Suture

Leading manufacturers include Acufex Microsurgical, Inc., Concept, Inc. and Ethicon, Inc..

20
Total
20
Cleared
103d
Avg days
1977
Since

FDA 510(k) Cleared Retention Device, Suture Devices (Product Code KGS)

20 devices
1–20 of 20
Cleared Jan 28, 2003
SOFT TISSUE ANCHORING WASHERS
K030031
Accu-Speed, Incorporated
General & Plastic Surgery · 25d
Cleared Mar 12, 2002
RBM
K020480
Smith & Nephew, Inc.
General & Plastic Surgery · 27d
Cleared Feb 25, 1997
SUTURE LOCK
K964935
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 77d
Cleared Jun 30, 1995
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740
Acufex Microsurgical, Inc.
General & Plastic Surgery · 449d
Cleared Nov 09, 1993
MITEK CONE WASHER
K930675
Mitek Surgical Products, Inc.
General & Plastic Surgery · 273d
Cleared Aug 29, 1991
VENTROFIL TENSION RELIEF SUTURE SET
K904435
Aesculap, Inc.
General & Plastic Surgery · 335d
Cleared Apr 17, 1991
TRAY DOUGH
K911225
The Hygenic Corp.
General & Plastic Surgery · 27d
Cleared Oct 02, 1990
SUTURE TENSION ADJUSTMENT REEL
K904136
Surgical Systems, Inc.
General & Plastic Surgery · 26d
Cleared May 09, 1990
SURGICAL RETENTION BAR
K902001
Acufex Microsurgical, Inc.
General & Plastic Surgery · 7d
Cleared Nov 20, 1989
ACUFEX FIXATION BUTTON
K896310
Acufex Microsurgical, Inc.
General & Plastic Surgery · 19d
Cleared Aug 11, 1989
DERMACARE TIE HOLDER
K893995
Dermacare
General & Plastic Surgery · 67d
Cleared Feb 27, 1989
ACUFEX FIXATION BUTTON
K884565
Acufex Microsurgical, Inc.
General & Plastic Surgery · 118d
Cleared Aug 23, 1988
SUTURE RETENTION DEVICE
K883299
Edwards Orthopaedics Div., Baxter Healthcare Corp.
General & Plastic Surgery · 19d
Cleared Sep 16, 1987
HEWSON A.C.L. GUIDE SET
K872608
Concept, Inc.
General & Plastic Surgery · 72d
Cleared Sep 29, 1986
LE VEEN WOUND SPLINT
K863570
Tek-Aid, Inc.
General & Plastic Surgery · 17d
Cleared May 23, 1984
BIOMER * PLEDGET SUTURE BUTTRESS
K832138
Ethicon, Inc.
General & Plastic Surgery · 327d
Cleared Mar 23, 1982
CRUCIATE LIGAMENT BUTTON
K813581
Biomet, Inc.
General & Plastic Surgery · 85d
Cleared Nov 20, 1981
ETHICON* SURGICAL SUTURES W/COMPRESS BOL
K812819
Ethicon, Inc.
General & Plastic Surgery · 44d
Cleared Nov 05, 1979
HEWSON LIGAMENT BUTTON
K792004
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 33d
Cleared Sep 02, 1977
SUTURE RETENTION CLAMP
K771554
Concept, Inc.
General & Plastic Surgery · 21d

About Product Code KGS - Regulatory Context