CLOSED CHEST DRAINAGE SET W/SUTURES
FDA 510(k) clearance K873377 · decided 1987-10-28
Clearance details
- K-number
- K873377
- Device name
- CLOSED CHEST DRAINAGE SET W/SUTURES
- Applicant
- Gish Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-24
- Decision date
- 1987-10-28
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- GBS
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ATRIUMS PDR THORACIC CATHETER (K912645) | Atrium Medical Corp. | 1991-09-13 |
| AXIOM ATRAUM WOUND DRAINS (K883887) | Axiom, Inc. | 1989-02-17 |
| INTRODUCTION/DRAINAGE CATHETER & ACCESS (K881873) | Sheridan Catheter Corp. | 1988-05-18 |
| URESIL WOUND DRAIN TROCAR (K880895) | Uresil Corp. | 1988-03-14 |
| NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (K880376) | Genesis Industries, Inc. | 1988-02-16 |
| AN3000 MAHONEY DRAIN (K872460) | H.W. Andersen Products, Inc. | 1987-07-23 |
| AN3100 MULHOLLAND DRAIN (K872459) | H.W. Andersen Products, Inc. | 1987-07-21 |
| AN3500 WORTH DRAIN (K872457) | H.W. Andersen Products, Inc. | 1987-07-21 |
| HCI ALL PURPOSE DRAIN/CATHETER SET (K870015) | Health Care Innovations, Inc. | 1987-02-06 |
| URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (K863560) | Uresil Corp. | 1986-09-29 |
| THORACIC CATHETER (CHEST DRAINAGE TUBE) (K863142) | Sheridan Catheter Corp. | 1986-08-29 |
| AXIOM TROCAR THORACIC CATHETER (K863247) | Axiom Medical, Inc. | 1986-08-29 |
Recalls involving this device
No recalls on record reference this clearance.