SHARTPOINT EYED NEEDLES
FDA 510(k) clearance K813589 · decided 1982-01-18
Clearance details
- K-number
- K813589
- Device name
- SHARTPOINT EYED NEEDLES
- Applicant
- S. Jackson, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-28
- Decision date
- 1982-01-18
- Days to decision
- 21 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
- 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 |
|---|---|---|
| NON-STERILE SUTURE NEEDLES (K881394) | China National Medicines C/O Havel'S | 1988-04-08 |
| 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 |
| UNIVERSAL SUTURE PASSER (K812566) | Ortho Pared Instruments, Inc. | 1981-11-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SUPRAMID EXTRA SUTURES (N80838/S017) | S. Jackson, Inc. | 1990-01-26 |
| SUPRAMID EXTRA SUTURES (N80838/S016) | S. Jackson, Inc. | 1989-10-19 |
| SUPRAMID EXTRA SUTURES (N80838/S014) | S. Jackson, Inc. | 1989-08-02 |
| SUPRAMID EXTRA SUTURES (N80838/S015) | S. Jackson, Inc. | 1989-06-08 |
| SUPRAMID EXTRA SUTURES (N80838/S013) | S. Jackson, Inc. | 1988-08-31 |
| SUPRAMID EXTRA SUTURES (N80838/S012) | S. Jackson, Inc. | 1987-09-09 |
| SUPRAMID EXTRA SUTURES (N80838/S011) | S. Jackson, Inc. | 1987-06-29 |
| SUPRAMID EXTRA SUTURES (N80838/S010) | S. Jackson, Inc. | 1986-08-05 |