DISPOSABLE SKIN STAPLER
FDA 510(k) clearance K830768 · decided 1983-04-12
Clearance details
- K-number
- K830768
- Device name
- DISPOSABLE SKIN STAPLER
- Applicant
- Surgeons Choice, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-11
- Decision date
- 1983-04-12
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- FZQ
- Device class
- 1
- Regulation number
- 878.4320
- 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 Surgeons Choice
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 |
|---|---|---|
| RANEY CLIP (K884783) | Alto Development Corp. | 1988-11-30 |
| LEUKOCLIP(R) (K873744) | Beiersdorf, Inc. | 1987-09-30 |
| ONE TIME DISPOSABLE SKIN STAPLER (K830704) | Acme United Corp. | 1983-04-12 |
| SURGICAL PRODUCTS, SKIN STAPLE REMOVER (K822963) | Temp-Stik Corp. | 1982-11-08 |
| COMPLETE (K822145) | Richard-Allan Medical Ind., Inc. | 1982-10-22 |
Recalls involving this device
No recalls on record reference this clearance.