TITANIUM HEMOSTATIC CLIP
FDA 510(k) clearance K972745 · decided 1997-10-21
Clearance details
- K-number
- K972745
- Device name
- TITANIUM HEMOSTATIC CLIP
- Applicant
- Eisner USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-23
- Decision date
- 1997-10-21
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MCH
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, 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 |
|---|---|---|
| RESOLUTION HEMOSTASIS CLIPPING DEVICE (K040148) | Boston Scientific Corp | 2004-04-22 |
| ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) (K896998) | S.P.K. Technology, Inc. | 1990-06-01 |
Recalls involving this device
No recalls on record reference this clearance.