INVENDO C20 COLONOSCOPY SYSTEM
FDA 510(k) clearance K100624 · decided 2012-02-23
Clearance details
- K-number
- K100624
- Device name
- INVENDO C20 COLONOSCOPY SYSTEM
- Applicant
- Invendo Medical Gbmh
- Decision
- Substantially Equivalent
- Date received
- 2010-03-04
- Decision date
- 2012-02-23
- Days to decision
- 721 days
- Clearance type
- Traditional
- Product code
- FDF
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kissing, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.