INSERTEASE
FDA 510(k) clearance K092829 · decided 2009-12-02
Clearance details
- K-number
- K092829
- Device name
- INSERTEASE
- Applicant
- Christcot Medical Company
- Decision
- Substantially Equivalent
- Date received
- 2009-09-15
- Decision date
- 2009-12-02
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- OOW
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sudbury, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.