FDA Product Code
FDA Product Code GBS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4200
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K912645 | ATRIUMS PDR THORACIC CATHETER | Atrium Medical Corp. | 1991-09-13 | Traditional | PDF ↗ |
| K883887 | AXIOM ATRAUM WOUND DRAINS | Axiom, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K881873 | INTRODUCTION/DRAINAGE CATHETER & ACCESS | Sheridan Catheter Corp. | 1988-05-18 | Traditional | PDF ↗ |
| K880895 | URESIL WOUND DRAIN TROCAR | Uresil Corp. | 1988-03-14 | Traditional | PDF ↗ |
| K880376 | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | Genesis Industries, Inc. | 1988-02-16 | Traditional | PDF ↗ |
| K873377 | CLOSED CHEST DRAINAGE SET W/SUTURES | Gish Biomedical, Inc. | 1987-10-28 | Traditional | PDF ↗ |
| K872460 | AN3000 MAHONEY DRAIN | H.W. Andersen Products, Inc. | 1987-07-23 | Traditional | PDF ↗ |
| K872459 | AN3100 MULHOLLAND DRAIN | H.W. Andersen Products, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K872457 | AN3500 WORTH DRAIN | H.W. Andersen Products, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K870015 | HCI ALL PURPOSE DRAIN/CATHETER SET | Health Care Innovations, Inc. | 1987-02-06 | Traditional | PDF ↗ |
| K863560 | URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA | Uresil Corp. | 1986-09-29 | Traditional | PDF ↗ |
| K863247 | AXIOM TROCAR THORACIC CATHETER | Axiom Medical, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K863142 | THORACIC CATHETER (CHEST DRAINAGE TUBE) | Sheridan Catheter Corp. | 1986-08-29 | Traditional | PDF ↗ |
| K862584 | OSTEOTOMY DRAINAGE TUBE | Treace Medical, Inc. | 1986-08-12 | Traditional | PDF ↗ |
| K862767 | SILICONE SUMP DRAIN | Sil-Med Corp. | 1986-08-07 | Traditional | PDF ↗ |
| K854418 | ROUND SUCTION DRAIN | Sil-Med Corp. | 1985-11-19 | Traditional | PDF ↗ |
| K853131 | THORO/CATH STRAIGHT THORACIC RIGHT ANGLE | J. H. Emerson Co. | 1985-09-05 | Traditional | PDF ↗ |
| K852241 | AXIOM ATRAUM TROCAR CATHETER | Axiom Medical, Inc. | 1985-06-14 | Traditional | PDF ↗ |
| K851048 | CHEST CATHETERS/THORACIC CATHETERS | Medovations, Inc. | 1985-06-05 | Traditional | PDF ↗ |
| K843906 | SNYDER HEMOVAC WOUND DRAINAGE DEVICES | Snyder Laboratories, Inc. | 1984-11-05 | Traditional | PDF ↗ |
| K832416 | AXIOM HYDROMER WOUND DRAINS | Axiom Medical, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K822318 | ARGYLE MEDIASTINAL DRAIN | Sherwood Medical Co. | 1982-08-27 | Traditional | PDF ↗ |
| K813463 | SIL-V-UR CHEST CATHETER | C.R. Bard, Inc. | 1982-02-12 | Traditional | PDF ↗ |
| K813587 | DISPOSABLE THORACIC CATHETER | Texas Medical Products, Inc. | 1982-01-12 | Traditional | PDF ↗ |
| K810158 | DAVOL SILICONE SHEATH SUMP DRAIN | C.R. Bard, Inc. | 1981-02-13 | Traditional | PDF ↗ |
| K810071 | STERILE SILICONE TUBING | Medspec Corp. | 1981-02-12 | Traditional | PDF ↗ |
| K802318 | ARGYLE SILICONE THORACIC CATHETER | Sherwood Medical Co. | 1980-10-23 | Traditional | PDF ↗ |
Product code GBS · Class I · General, Plastic Surgery. Data: openFDA.