PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
FDA 510(k) clearance DEN110016 · decided 2012-04-30
Clearance details
- K-number
- DEN110016
- Device name
- PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
- Applicant
- Ethicon Endo-Surgery
- Decision
- Unknown
- Date received
- 2011-09-21
- Decision date
- 2012-04-30
- Days to decision
- 222 days
- Clearance type
- Post-NSE
- Product code
- OXT
- Device class
- 2
- Regulation number
- 878.4805
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.