NON-STERILE SUTURE NEEDLES
FDA 510(k) clearance K881394 · decided 1988-04-08
Clearance details
- K-number
- K881394
- Device name
- NON-STERILE SUTURE NEEDLES
- Applicant
- China National Medicines C/O Havel'S
- Decision
- Substantially Equivalent
- Date received
- 1988-04-04
- Decision date
- 1988-04-08
- Days to decision
- 4 days
- Clearance type
- Traditional
- Product code
- GDL
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cincinnati, OH, 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 |
|---|---|---|
| 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES (K851781) | Artiberia | 1985-06-20 |
| 25-450 TO 25-540 VARIOUS SUTURE FORCEPS (K851782) | Artiberia | 1985-06-20 |
| SHARTPOINT EYED NEEDLES (K813589) | S. Jackson, Inc. | 1982-01-18 |
| UNIVERSAL SUTURE PASSER (K812566) | Ortho Pared Instruments, Inc. | 1981-11-10 |
Recalls involving this device
No recalls on record reference this clearance.