AUTO SUTURE DISPOSABLE GIA SURG. STAPLER
FDA 510(k) clearance K801590 · decided 1980-08-04
Clearance details
- K-number
- K801590
- Device name
- AUTO SUTURE DISPOSABLE GIA SURG. STAPLER
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1980-07-11
- Decision date
- 1980-08-04
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- FHM
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, 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 |
|---|---|---|
| AUTO SUTURE DISP. 30, ETC. & SURG. STAP (K801589) | United States Surgical, A Division of Tyco Healthc | 1980-08-04 |
Recalls involving this device
No recalls on record reference this clearance.