MODIFICATION TO IMPLANTABLE CLIP
FDA 510(k) clearance K011236 · decided 2001-05-14
Clearance details
- K-number
- K011236
- Device name
- MODIFICATION TO IMPLANTABLE CLIP
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-23
- Decision date
- 2001-05-14
- Days to decision
- 21 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
- Rancho Santa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels i recall (Z-1621-2016) | Applied Medical Resources Corp | 2016-05-06 |