GBS — Catheter, Ventricular, General & Plastic Surgery Class I
FDA product code GBS covers "Catheter, Ventricular, General & Plastic Surgery", a Class I medical device regulated under 21 CFR 878.4200. 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
- GBS
- Device Class
- Class I
- Regulation Number
- 878.4200
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K912645 | atrium medical | ATRIUMS PDR THORACIC CATHETER | September 13, 1991 |
| K883887 | axiom | AXIOM ATRAUM WOUND DRAINS | February 17, 1989 |
| K881873 | sheridan catheter | INTRODUCTION/DRAINAGE CATHETER & ACCESS | May 18, 1988 |
| K880895 | uresil | URESIL WOUND DRAIN TROCAR | March 14, 1988 |
| K880376 | genesis industries | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | February 16, 1988 |
| K873377 | gish biomedical | CLOSED CHEST DRAINAGE SET W/SUTURES | October 28, 1987 |
| K872460 | h.w. andersen products | AN3000 MAHONEY DRAIN | July 23, 1987 |
| K872457 | h.w. andersen products | AN3500 WORTH DRAIN | July 21, 1987 |
| K872459 | h.w. andersen products | AN3100 MULHOLLAND DRAIN | July 21, 1987 |
| K870015 | health care innovations | HCI ALL PURPOSE DRAIN/CATHETER SET | February 6, 1987 |
| K863560 | uresil | URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA | September 29, 1986 |
| K863247 | axiom medical | AXIOM TROCAR THORACIC CATHETER | August 29, 1986 |
| K863142 | sheridan catheter | THORACIC CATHETER (CHEST DRAINAGE TUBE) | August 29, 1986 |
| K862584 | treace medical | OSTEOTOMY DRAINAGE TUBE | August 12, 1986 |
| K862767 | sil-med | SILICONE SUMP DRAIN | August 7, 1986 |
| K854418 | sil-med | ROUND SUCTION DRAIN | November 19, 1985 |
| K853131 | j. h. emerson | THORO/CATH STRAIGHT THORACIC RIGHT ANGLE | September 5, 1985 |
| K852241 | axiom medical | AXIOM ATRAUM TROCAR CATHETER | June 14, 1985 |
| K851048 | medovations | CHEST CATHETERS/THORACIC CATHETERS | June 5, 1985 |
| K843906 | snyder laboratories | SNYDER HEMOVAC WOUND DRAINAGE DEVICES | November 5, 1984 |