Panels › General, Plastic Surgery › Product code KGS · Class 1
Retention Device, Suture
Regulation 878.4930
0510(k)s in 12 months (20 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in KGS
| Company | 510(k)s | Recalls |
|---|---|---|
| Acufex Microsurgical, Inc. | 4 | 0 |
| Concept, Inc. | 2 | 0 |
| ETHICON, Inc. | 2 | 0 |
| Accu-Speed, Incorporated | 1 | 0 |
| Aesculap, Inc. | 1 | 0 |
| Biomet, Inc. | 1 | 0 |
| Dermacare | 1 | 0 |
| Drs Vascular, Inc | 0 | 1 |
| Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1 | 0 |
| The Hygenic Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2003 | K030031 | SOFT TISSUE ANCHORING WASHERS Accu-Speed, Incorporated | KGS |
| Mar 12, 2002 | K020480 | RBM Smith & Nephew, Inc. | KGS |
| Feb 25, 1997 | K964935 | SUTURE LOCK Smith & Nephew Endoscopy, Inc. | KGS |
| Jun 30, 1995 | K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON Acufex Microsurgical, Inc. | KGS |
| Nov 9, 1993 | K930675 | MITEK CONE WASHER Mitek Surgical Products, Inc. | KGS |
| Aug 29, 1991 | K904435 | VENTROFIL TENSION RELIEF SUTURE SET Aesculap, Inc. | KGS |
| Apr 17, 1991 | K911225 | TRAY DOUGH The Hygenic Corp. | KGS |
| Oct 2, 1990 | K904136 | SUTURE TENSION ADJUSTMENT REEL Surgical Systems, Inc. | KGS |
| May 9, 1990 | K902001 | SURGICAL RETENTION BAR Acufex Microsurgical, Inc. | KGS |
| Nov 20, 1989 | K896310 | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE Acufex Microsurgical, Inc. | KGS |
| Aug 11, 1989 | K893995 | DERMACARE TIE HOLDER Dermacare | KGS |
| Feb 27, 1989 | K884565 | ACUFEX FIXATION BUTTON Acufex Microsurgical, Inc. | KGS |
| Aug 23, 1988 | K883299 | SUTURE RETENTION DEVICE Edwards Orthopaedics Div., Baxter Healthcare Corp. | KGS |
| Sep 16, 1987 | K872608 | HEWSON A.C.L. GUIDE SET Concept, Inc. | KGS |
| Sep 29, 1986 | K863570 | LE VEEN WOUND SPLINT Tek-Aid, Inc. | KGS |
| May 23, 1984 | K832138 | BIOMER * PLEDGET SUTURE BUTTRESS ETHICON, Inc. | KGS |
| Mar 23, 1982 | K813581 | CRUCIATE LIGAMENT BUTTON Biomet, Inc. | KGS |
| Nov 20, 1981 | K812819 | ETHICON* SURGICAL SUTURES W/COMPRESS BOL ETHICON, Inc. | KGS |
| Nov 5, 1979 | K792004 | HEWSON LIGAMENT BUTTON Richard'S Medical Equip., Inc. | KGS |
| Sep 2, 1977 | K771554 | SUTURE RETENTION CLAMP Concept, Inc. | KGS |
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