RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA 510(k) clearance K040148 · decided 2004-04-22
Clearance details
- K-number
- K040148
- Device name
- RESOLUTION HEMOSTASIS CLIPPING DEVICE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-01-23
- Decision date
- 2004-04-22
- 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
- Natick,, 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 |
|---|---|---|
| TITANIUM HEMOSTATIC CLIP (K972745) | Eisner USA, Inc. | 1997-10-21 |
| ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) (K896998) | S.P.K. Technology, Inc. | 1990-06-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel recall (Z-1895-2009) | Boston Scientific Corporation | 2009-09-02 |
| Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel recall (Z-1896-2009) | Boston Scientific Corporation | 2009-09-02 |