Cleared Traditional

Genadyne Hybrid Foam Dressings

K221888 · Genadyne Biotechnologies, Inc. · General & Plastic Surgery

Jun 2023

Decision

348d

Days

Class 2

Risk

About This 510(k) Submission

K221888 is an FDA 510(k) clearance for the Genadyne Hybrid Foam Dressings, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Genadyne Biotechnologies, Inc. (Hicksville, US). The FDA issued a Cleared decision on June 12, 2023, 348 days after receiving the submission on June 29, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number	K221888 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2022
Decision Date	June 12, 2023
Days to Decision	348 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OMP — Negative Pressure Wound Therapy Powered Suction Pump
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4780
Definition	For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.