CleverLock Guidewire Locking Device and Biopsy Cap— 510(k) K190164
Substantially EquivalentOlympus Surgical Technologies America
FDA 510(k) clearance K190164 for CleverLock Guidewire Locking Device and Biopsy Cap, Substantially Equivalent on 2019-04-04. Applicant: Olympus Surgical Technologies America. Device class: 2.
Clearance details
- Applicant
- Olympus Surgical Technologies America
- Product code
- Code ODC
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.