VARI-PASS VARIABLE LENGTH ACCESS SHEATH— 510(k) K123170
Substantially EquivalentOlympus Surgical Technologies America
FDA 510(k) clearance K123170 for VARI-PASS VARIABLE LENGTH ACCESS SHEATH, Substantially Equivalent on 2013-02-04. Applicant: Olympus Surgical Technologies America. Device class: 2.
Clearance details
- Applicant
- Olympus Surgical Technologies America
- Product code
- Code KNY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Southborough, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.