LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
FDA 510(k) clearance K965162 · decided 1997-02-12
Clearance details
- K-number
- K965162
- Device name
- LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
- Applicant
- Lukens Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-24
- Decision date
- 1997-02-12
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N recall (Z-1534-2024) | SURGICAL SPECIALTIES | 2024-04-12 |