OPUS SMARTSTITCH SUTURE DEVICE
FDA 510(k) clearance K070671 · decided 2007-04-06
Clearance details
- K-number
- K070671
- Device name
- OPUS SMARTSTITCH SUTURE DEVICE
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-12
- Decision date
- 2007-04-06
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- OCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OPUS SmartStitch Product Number OM-8178 is a suture cartridge For use in approximation and recall (Z-0612-2012) | Innovatech Medical Resources L.P. | 2012-01-11 |
| OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer recall (Z-0613-2012) | Innovatech Medical Resources L.P. | 2012-01-11 |