KGS — Retention Device, Suture Class I
FDA Device Classification
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 |