C2 CryoBalloon EndoGrip— 510(k) K193036
Substantially EquivalentPentax Medical, A Division of Pentax of America, Inc.
FDA 510(k) clearance K193036 for C2 CryoBalloon EndoGrip, Substantially Equivalent on 2019-11-22. Applicant: Pentax Medical, A Division of Pentax of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Pentax Medical, A Division of Pentax of America, Inc.
- Product code
- Code OCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood, Ca, CA, US
Recent devices under product code OCX
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