Identifiers
- 510(k) Number
- K150381 FDA 510(k)
- FDA Product Code
- KPL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5220 FDA 510(k)
- Regulation Number
- 876.5220 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Aqua Cleanse is a Colonic Irrigation System used in Gastroenterology and Urology. It is a Class II medical device that received FDA 510(k) clearance under K150381 on September 11, 2015, and was found substantially equivalent to a predicate device.
The device is manufactured by Quality Medical Supply, Inc. and is identified by product code KPL. It is supplied as a non-sterile, reusable system intended for use in clinical settings under professional supervision. No claims regarding sterility, single-use status, MRI safety, storage conditions, or specific sizes are provided in the data.
Frequently asked questions
What is the Aqua Cleanse device used for?
The Aqua Cleanse is a colonic irrigation system intended for use in gastroenterology and urology procedures, designed to deliver fluid to the colon under professional supervision in clinical settings.
Is the Aqua Cleanse sterile or single-use?
The Aqua Cleanse is supplied as a non-sterile, reusable system, meaning it is not provided sterile and is designed for multiple uses after appropriate reprocessing by the healthcare facility.
What regulatory pathway was used for Aqua Cleanse clearance?
Aqua Cleanse received FDA 510(k) clearance under submission K150381 on September 11, 2015, based on a determination of substantial equivalence to a legally marketed predicate device.
Who manufactures the Aqua Cleanse and what is its product code?
The Aqua Cleanse is manufactured by Quality Medical Supply, Inc., and is identified by the product code KPL in the FDA’s device classification system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K150381 FDA 510(k) - AQUA CLEANSE | Quality Medical Supply, Inc., QUALITY MEDICAL SUPPLY, INC. 01 QMS - AQUA CLEANSE - RevMed, QUALITY MEDICAL SUPPLY, INC. - RevMed, AQUA CLEANSE (K150381) — FDA 510 (k) | Innolitics, Quality Medical Supply - Overview, News & Similar companies - ZoomInfo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150381 | Class II | Active |
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Manufacturer
- Manufacturer
- Quality Medical Supply, Inc.
Sources (1)
- FDA 510(k) K150381 24 fields · synced Sep 27, 2026