MODIFIED PGL ABSORBABLE STAPLE*
FDA 510(k) clearance K900069 · decided 1990-04-16
Clearance details
- K-number
- K900069
- Device name
- MODIFIED PGL ABSORBABLE STAPLE*
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1990-01-04
- Decision date
- 1990-04-16
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- GDG
- 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 |
|---|---|---|
| SKIN HOOKS, VARIOUS TYPES (K891898) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| RAYLOR(TM) DISSECTING HOOK (K864425) | Cedar Surgical, Inc. | 1986-12-12 |
| BRIMFIELD CANNULATED GRASPING HOOKS (K843136) | Brimfield Scientific Instruments | 1984-09-25 |
| SURGICAL HOOKS, VARIOUS (K841010) | Premier Dental Products Co. | 1984-05-01 |
| SURGICAL RETRACTOR & ELASTIC STAYS, DISP (K812562) | Humboldt Products | 1981-10-02 |
| MIDDLE EAR PICKS, HOOKS CURETTES, (K791120) | Xomed, Inc. | 1979-07-10 |
| NERVE APPROXIMATER (K780289) | Edward Weck, Inc. | 1978-06-14 |
| ABRAMSON TRACHEA HOOK & RETRACTOR (K771190) | Edward Weck, Inc. | 1977-07-11 |
| DERMAHOOK #382-805 (K771187) | Edward Weck, Inc. | 1977-07-11 |
Recalls involving this device
No recalls on record reference this clearance.