Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
FDA 510(k) clearance K153258 · decided 2016-04-05
Clearance details
- K-number
- K153258
- Device name
- Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
- Applicant
- Surgical Instrument Service and Savings (Dba Medline Renewal
- Decision
- Substantially Equivalent
- Date received
- 2015-11-10
- Decision date
- 2016-04-05
- Days to decision
- 147 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.