SKIN STAPLE EXTRACTOR
FDA 510(k) clearance K811887 · decided 1981-07-27
Clearance details
- K-number
- K811887
- Device name
- SKIN STAPLE EXTRACTOR
- Applicant
- Sierra Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-01
- Decision date
- 1981-07-27
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- KBC
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- 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 |
|---|---|---|
| AUTO SUTURE PSS SKIN STAPLING INSTRUMENT (K810187) | United States Surgical, A Division of Tyco Healthc | 1981-03-20 |
| AUTO SUTURE GAS POWERED DISP. LDS STAPL (K810188) | United States Surgical, A Division of Tyco Healthc | 1981-03-20 |
| JOSEPH SAW (K772379) | Edward Weck, Inc. | 1978-02-02 |
Recalls involving this device
No recalls on record reference this clearance.