Product code KGS— General, Plastic Surgery

FDA has cleared 20 devices under product code KGS between 1977 and 2003, filed by 15 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20031 clearance
• 20021 clearance
• 19971 clearance
• 19951 clearance
• 19931 clearance
• 19912 clearances
• 19902 clearances
• 19893 clearances
• 19881 clearance
• 19871 clearance
• 19861 clearance
• 19841 clearance
• 19821 clearance
• 19811 clearance
• 19791 clearance

• Acufex Microsurgical, Inc.4 clearances
• ETHICON, Inc.2 clearances
• Concept, Inc.2 clearances
• The Hygenic Corp.1 clearance
• Tek-Aid, Inc.1 clearance
• Surgical Systems, Inc.1 clearance
• Smith & Nephew, Inc.1 clearance
• Smith & Nephew Endoscopy, Inc.1 clearance
• Richard'S Medical Equip., Inc.1 clearance
• Mitek Surgical Products, Inc.1 clearance

• K030031 — SOFT TISSUE ANCHORING WASHERSAccu-Speed, Incorporated·2003-01-28
• K020480 — RBMSmith & Nephew, Inc.·2002-03-12
• K964935 — SUTURE LOCKSmith & Nephew Endoscopy, Inc.·1997-02-25
• K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.·1995-06-30
• K930675 — MITEK CONE WASHERMitek Surgical Products, Inc.·1993-11-09
• K904435 — VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.·1991-08-29
• K911225 — TRAY DOUGHThe Hygenic Corp.·1991-04-17
• K904136 — SUTURE TENSION ADJUSTMENT REELSurgical Systems, Inc.·1990-10-02
• K902001 — SURGICAL RETENTION BARAcufex Microsurgical, Inc.·1990-05-09
• K896310 — ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGEAcufex Microsurgical, Inc.·1989-11-20
• K893995 — DERMACARE TIE HOLDERDermacare·1989-08-11
• K884565 — ACUFEX FIXATION BUTTONAcufex Microsurgical, Inc.·1989-02-27
• K883299 — SUTURE RETENTION DEVICEEdwards Orthopaedics Div., Baxter Healthcare Corp.·1988-08-23
• K872608 — HEWSON A.C.L. GUIDE SETConcept, Inc.·1987-09-16
• K863570 — LE VEEN WOUND SPLINTTek-Aid, Inc.·1986-09-29
• K832138 — BIOMER * PLEDGET SUTURE BUTTRESSETHICON, Inc.·1984-05-23
• K813581 — CRUCIATE LIGAMENT BUTTONBiomet, Inc.·1982-03-23
• K812819 — ETHICON* SURGICAL SUTURES W/COMPRESS BOLETHICON, Inc.·1981-11-20
• K792004 — HEWSON LIGAMENT BUTTONRichard'S Medical Equip., Inc.·1979-11-05
• K771554 — SUTURE RETENTION CLAMPConcept, Inc.·1977-09-02