KGS — Retention Device, Suture Class I
FDA product code KGS covers "Retention Device, Suture", a Class I medical device regulated under 21 CFR 878.4930. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KGS
- Device Class
- Class I
- Regulation Number
- 878.4930
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K030031 | accu-speed, incorporated | SOFT TISSUE ANCHORING WASHERS | January 28, 2003 |
| K020480 | smith and nephew | RBM | March 12, 2002 |
| K964935 | smith and nephew endoscopy | SUTURE LOCK | February 25, 1997 |
| K941740 | acufex microsurgical | ACUFEX ROTATOR CUFF FIXATION BUTTON | June 30, 1995 |
| K930675 | mitek surgical products | MITEK CONE WASHER | November 9, 1993 |
| K904435 | aesculap | VENTROFIL TENSION RELIEF SUTURE SET | August 29, 1991 |
| K911225 | hygenic | TRAY DOUGH | April 17, 1991 |
| K904136 | surgical systems | SUTURE TENSION ADJUSTMENT REEL | October 2, 1990 |
| K902001 | acufex microsurgical | SURGICAL RETENTION BAR | May 9, 1990 |
| K896310 | acufex microsurgical | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE | November 20, 1989 |
| K893995 | dermacare | DERMACARE TIE HOLDER | August 11, 1989 |
| K884565 | acufex microsurgical | ACUFEX FIXATION BUTTON | February 27, 1989 |
| K883299 | edwards orthopaedics div., baxter healthcare | SUTURE RETENTION DEVICE | August 23, 1988 |
| K872608 | concept | HEWSON A.C.L. GUIDE SET | September 16, 1987 |
| K863570 | tek-aid | LE VEEN WOUND SPLINT | September 29, 1986 |
| K832138 | ethicon | BIOMER * PLEDGET SUTURE BUTTRESS | May 23, 1984 |
| K813581 | biomet | CRUCIATE LIGAMENT BUTTON | March 23, 1982 |
| K812819 | ethicon | ETHICON* SURGICAL SUTURES W/COMPRESS BOL | November 20, 1981 |
| K792004 | richard medical equip | HEWSON LIGAMENT BUTTON | November 5, 1979 |
| K771554 | concept | SUTURE RETENTION CLAMP | September 2, 1977 |