Wavicide(R) -01

by Wave Energy Systems, Inc.

510(k) K914749

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

510(k) K914749↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK914749	Date10 Aug 1995Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K914749
FDA Product Code: MED

Device Class: Class II
Regulation: 21 CFR Part 880.6885
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Wavicide-01 is a sterilant medical device designed for disinfection and sterilization of medical instruments and surfaces. It falls under the category of chemical sterilants, intended to eliminate microorganisms through chemical action, ensuring a sterile environment for healthcare applications in general hospital settings.

This device is supplied as a liquid formulation in various sizes, including 1-gallon and 32-ounce containers, and is intended for single-use or reusable medical instruments depending on the application. It is regulated under FDA 510(k) clearance (K914749) and classified as a Class II medical device. Storage and handling must comply with manufacturer guidelines to maintain efficacy and safety, though specific sterility or MRI safety information is not provided in the data.