SUTURE REMOVAL SET
FDA 510(k) clearance K770595 · decided 1977-05-23
Clearance details
- K-number
- K770595
- Device name
- SUTURE REMOVAL SET
- Applicant
- Abco Dealers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-28
- Decision date
- 1977-05-23
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- JOK
- Device class
- 1
- Regulation number
- 880.6820
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SUTURE REMOVAL KIT (K855131) | Dynarex Corp. | 1986-01-13 |
| UTILITY SCISSORS DISPOSABLE ITEMS (K843075) | Greene International Corp. | 1984-09-05 |
| DISPOSABLE SUTURE REMOVAL SCISSORS (K812555) | Medcare Products | 1981-11-16 |
| SHEAR, PLASTIC HANDLE UTILITY S-475-7 (K770481) | Acme United Corp. | 1977-04-29 |
| SUTURE CUTTER (K770163) | Concept, Inc. | 1977-03-30 |
| DRESSING CHANGE KIT (K761192) | Superior Plastic Products Corp. | 1977-02-28 |
Recalls involving this device
No recalls on record reference this clearance.