MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
FDA 510(k) clearance K031623 · decided 2003-07-03
Clearance details
- K-number
- K031623
- Device name
- MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
- Applicant
- Coalescent Surgical
- Decision
- Substantially Equivalent
- Date received
- 2003-05-23
- Decision date
- 2003-07-03
- Days to decision
- 41 days
- Clearance type
- Special
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100D recall (Z-2030-2010) | Medtronic Cardiovascular Revascularization & Surgical Therap | 2010-07-17 |
| VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomo recall (Z-1609-2008) | Medtronic Cardiac Surgery Technologies | 2008-09-16 |
| Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic recall (Z-0968-2007) | Medtronic Cardiac Surgery Technologies | 2007-06-27 |
| Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyroge recall (Z-0763-06) | Medtronic Cardiac Surgery Technologies | 2006-04-13 |