BIOKNOTLESS ANCHOR
FDA 510(k) clearance K002639 · decided 2001-05-11
Clearance details
- K-number
- K002639
- Device name
- BIOKNOTLESS ANCHOR
- Applicant
- Mitek Products
- Decision
- Substantially Equivalent
- Date received
- 2000-08-24
- Decision date
- 2001-05-11
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728 recall (Z-0610-06) | Depuy Mitek, a Johnson & Johnson Co. | 2006-03-15 |
| Depuy Mitek Bioknotless Anchor with Panacryl Suture Ref No. 212729 recall (Z-0611-06) | Depuy Mitek, a Johnson & Johnson Co. | 2006-03-15 |