UNIVERSAL SUTURE PASSER
FDA 510(k) clearance K812566 · decided 1981-11-10
Clearance details
- K-number
- K812566
- Device name
- UNIVERSAL SUTURE PASSER
- Applicant
- Ortho Pared Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-09
- Decision date
- 1981-11-10
- Days to decision
- 62 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ortho Pared Instruments
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| SHARTPOINT EYED NEEDLES (K813589) | S. Jackson, Inc. | 1982-01-18 |
Recalls involving this device
No recalls on record reference this clearance.