ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)
FDA 510(k) clearance K896998 · decided 1990-06-01
Clearance details
- K-number
- K896998
- Device name
- ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)
- Applicant
- S.P.K. Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-12
- Decision date
- 1990-06-01
- Days to decision
- 171 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
- Seal Beach, CA, 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 |
| TITANIUM HEMOSTATIC CLIP (K972745) | Eisner USA, Inc. | 1997-10-21 |
Recalls involving this device
No recalls on record reference this clearance.