VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
FDA 510(k) clearance K112349 · decided 2011-09-01
Clearance details
- K-number
- K112349
- Device name
- VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
- Applicant
- Covidien, Formerly US Surgical A Divison of Tyco H
- Decision
- Substantially Equivalent
- Date received
- 2011-08-16
- Decision date
- 2011-09-01
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- North Haven, CT, US
- Third-party review
- No
- Expedited review
- No
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