BIOPSY VALVE— 510(k) K111821
Substantially EquivalentEndochoice, Inc.
FDA 510(k) clearance K111821 for BIOPSY VALVE, Substantially Equivalent on 2011-07-28. Applicant: Endochoice, Inc.. Device class: 2.
Clearance details
- Applicant
- Endochoice, 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
- Traditional
- Location
- Alpharetta, GA, US
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