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Awesmosis

by Applied Water Engineering, Inc.

510(k) K945066

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945066 Date15 Dec 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FIP
Device Class
Class II
Regulation
21 CFR Part 876.5665
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Awesmosis is a water purification subsystem. It is designed for use in gastroenterology and urology applications.

The device is supplied by Applied Water Engineering, Inc. and received FDA 510(k) clearance on December 15, 1995 with decision code SESE. It is classified as a Class II device under product code FIP.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Awesmosis device used for?

    Awesmosis is a water purification subsystem designed for use in gastroenterology and urology applications, as stated in its device description and advisory committee classification.

  • How is the Awesmosis device supplied and by whom?

    The device is supplied by Applied Water Engineering, Inc., located at 2759 S. 300 W., Suite G, Salt Lake City, UT 84115, as indicated in the manufacturer and address fields.

  • What regulatory clearance does the Awesmosis device have?

    Awesmosis received FDA 510(k) clearance on December 15, 1995, with decision code SESE and K-number K945066, and is classified as a Class II device under product code FIP.