ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL
FDA 510(k) clearance K842953 · decided 1984-08-21
Clearance details
- K-number
- K842953
- Device name
- ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL
- Applicant
- All-Hands Medical Supply, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-27
- Decision date
- 1984-08-21
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- HRR
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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 |
|---|---|---|
| MICROSURGICAL SCISSORS (K890212) | Kinetic Medical Products | 1989-01-27 |
| SURGICAL SCISSORS (K890225) | Kinetic Medical Products | 1989-01-27 |
| TRIGEMINAL SCISSORS (K890261) | Kinetic Medical Products | 1989-01-27 |
| SCISSOR, LEFT (K873501) | Arthropedics, Inc. | 1987-11-02 |
| SCISSOR, RIGHT (K873502) | Arthropedics, Inc. | 1987-11-02 |
| 69-100 TO 69-114 VARIOUS CUTICLE SCISSORS (K851800) | Artiberia | 1985-06-20 |
| GENERAL UTILITY SURG. SCISSORS #460180- (K800721) | Edward Weck, Inc. | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.