MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
FDA 510(k) clearance K900487 · decided 1990-02-09
Clearance details
- K-number
- K900487
- Device name
- MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1990-01-23
- Decision date
- 1990-02-09
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GDH
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwalk, CT, 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 |
|---|---|---|
| MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE (K903419) | United States Surgical, A Division of Tyco Healthc | 1990-08-09 |
| GOUGES, ALEXANDER, BISHOP, LUCAS (K891901) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE (K874879) | United States Surgical, A Division of Tyco Healthc | 1987-12-17 |
| CHERMEL BONE GOUGES (K842822) | Cher Mel Corp. | 1984-08-02 |
| PARKES HUMP GAUGE STRAIGHT 7 (18 CM) (K760850) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-03 |
Recalls involving this device
No recalls on record reference this clearance.