Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
FDA 510(k) clearance K160740 · decided 2016-05-06
Clearance details
- K-number
- K160740
- Device name
- Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-17
- Decision date
- 2016-05-06
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- NLM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.