TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
FDA 510(k) clearance K862696 · decided 1986-07-30
Clearance details
- K-number
- K862696
- Device name
- TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-15
- Decision date
- 1986-07-30
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- HBT
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wilmington, MA, 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 |
|---|---|---|
| REFLEX(R) ECA (K924929) | Richard-Allan Medical | 1993-07-21 |
| TITANIUM LIGATING CLIPS (K896262) | Richard-Allan Medical Ind., Inc. | 1990-01-02 |
| DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI (K800318) | Edward Weck, Inc. | 1980-03-10 |
Recalls involving this device
No recalls on record reference this clearance.