BLUE ORTHOCORD SUTURE
FDA 510(k) clearance K043298 · decided 2004-12-10
Clearance details
- K-number
- K043298
- Device name
- BLUE ORTHOCORD SUTURE
- Applicant
- Depuy Mitek
- Decision
- Substantially Equivalent
- Date received
- 2004-11-30
- Decision date
- 2004-12-10
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- NEW
- Device class
- 2
- Regulation number
- 878.4840
- 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 |
|---|---|---|
| ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in g recall (Z-1172-2013) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2013-04-25 |
| ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 2 recall (Z-1173-2013) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2013-04-25 |
| ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalo recall (Z-1174-2013) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2013-04-25 |
| ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Produc recall (Z-1175-2013) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2013-04-25 |
| ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needl recall (Z-1176-2013) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2013-04-25 |
| Orthocord Blue Braided Composite Suture, DePuy Mitek, A Johnson & Johnson Company, Meets U recall (Z-1315-2009) | Ethicon, Inc. | 2009-05-12 |