OPUS SMARTSTITCH SUTURE DEVICE— 510(k) K070671
Substantially EquivalentArthrocare Corp.
FDA 510(k) clearance K070671 for OPUS SMARTSTITCH SUTURE DEVICE, Substantially Equivalent on 2007-04-06. Applicant: Arthrocare Corp.. Device class: 2.
Clearance details
- Applicant
- Arthrocare Corp.
- Product code
- Code OCW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
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Adverse events under product code OCW
product code OCW- Death
- 6
- Injury
- 443
- Malfunction
- 1,023
- Other
- 2
- Total
- 1,474
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.