Cleared Traditional

K161948 - Avance Gauze Dressing Kits

K161948 is an FDA 510(k) clearance for Avance Gauze Dressing Kits, manufactured by Molnlycke Health Care Us, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K161948 · Molnlycke Health Care Us, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
111d
Days
Class 2
Risk

K161948 is an FDA 510(k) clearance for the Avance Gauze Dressing Kits. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on November 3, 2016 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Molnlycke Health Care Us, LLC devices

FDA 510(k) Submission Details - K161948

510(k) Number K161948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2016
Decision Date November 03, 2016
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMP Device Classification - Class 2, Special Controls

Product Code OMP Negative Pressure Wound Therapy Powered Suction Pump
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 157
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K161948.
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
K160487 · Kci USA, Inc. · Dec 2016
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
K161128 · Medela AG · Dec 2016
Avance Foam Dressing Kit - XL
K161935 · Molnlycke Health Care Us, LLC · Nov 2016
Avance Tubing, Avance Y-Connector, Avance ViewPad
K161797 · Molnlycke Health Care Us, LLC · Oct 2016
RENASYS GO
K152163 · Smith & Nephew, Inc. · Sep 2016
RENASYS-G Gauze Dressing Kits with Soft Port
K162129 · Smith & Nephew, Inc. · Aug 2016