AQUA CLEANSE
FDA 510(k) clearance K150381 · decided 2015-09-11
Clearance details
- K-number
- K150381
- Device name
- AQUA CLEANSE
- Applicant
- Quality Medical Supply, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-18
- Decision date
- 2015-09-11
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- KPL
- Device class
- 2
- Regulation number
- 876.5220
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Surprise, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.