FDA Product Code
FDA Product Code KGS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4930
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K030031 | SOFT TISSUE ANCHORING WASHERS | Accu-Speed, Incorporated | 2003-01-28 | Traditional | PDF ↗ |
| K020480 | RBM | Smith & Nephew, Inc. | 2002-03-12 | Special | PDF ↗ |
| K964935 | SUTURE LOCK | Smith & Nephew Endoscopy, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Acufex Microsurgical, Inc. | 1995-06-30 | Traditional | PDF ↗ |
| K930675 | MITEK CONE WASHER | Mitek Surgical Products, Inc. | 1993-11-09 | Traditional | PDF ↗ |
| K904435 | VENTROFIL TENSION RELIEF SUTURE SET | Aesculap, Inc. | 1991-08-29 | Traditional | PDF ↗ |
| K911225 | TRAY DOUGH | The Hygenic Corp. | 1991-04-17 | Traditional | PDF ↗ |
| K904136 | SUTURE TENSION ADJUSTMENT REEL | Surgical Systems, Inc. | 1990-10-02 | Traditional | PDF ↗ |
| K902001 | SURGICAL RETENTION BAR | Acufex Microsurgical, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K896310 | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE | Acufex Microsurgical, Inc. | 1989-11-20 | Traditional | PDF ↗ |
| K893995 | DERMACARE TIE HOLDER | Dermacare | 1989-08-11 | Traditional | PDF ↗ |
| K884565 | ACUFEX FIXATION BUTTON | Acufex Microsurgical, Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K883299 | SUTURE RETENTION DEVICE | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1988-08-23 | Traditional | PDF ↗ |
| K872608 | HEWSON A.C.L. GUIDE SET | Concept, Inc. | 1987-09-16 | Traditional | PDF ↗ |
| K863570 | LE VEEN WOUND SPLINT | Tek-Aid, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K832138 | BIOMER * PLEDGET SUTURE BUTTRESS | ETHICON, Inc. | 1984-05-23 | Traditional | PDF ↗ |
| K813581 | CRUCIATE LIGAMENT BUTTON | Biomet, Inc. | 1982-03-23 | Traditional | PDF ↗ |
| K812819 | ETHICON* SURGICAL SUTURES W/COMPRESS BOL | ETHICON, Inc. | 1981-11-20 | Traditional | PDF ↗ |
| K792004 | HEWSON LIGAMENT BUTTON | Richard'S Medical Equip., Inc. | 1979-11-05 | Traditional | PDF ↗ |
| K771554 | SUTURE RETENTION CLAMP | Concept, Inc. | 1977-09-02 | Traditional | PDF ↗ |
Product code KGS · Class I · General, Plastic Surgery. Data: openFDA.