TUBECLEAR
FDA 510(k) clearance K121571 · decided 2012-06-13
Clearance details
- K-number
- K121571
- Device name
- TUBECLEAR
- Applicant
- Actuated Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-29
- Decision date
- 2012-06-13
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bellefonte, PA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.