Cleared Traditional

K163430 - Prontosan Wound Gel

K163430 · B.Braun Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
167d
Days
-
Risk

K163430 is an FDA 510(k) clearance for the Prontosan Wound Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on May 23, 2017 after a review of 167 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K163430

510(k) Number K163430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2016
Decision Date May 23, 2017
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 634
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K163430.
BD ChloraShield IV Dressing with CHG Antimicrobial
K170407 · Avery Dennison Belgie Bvba · Jul 2017
Cerdak Basic
K153138 · Bu Polysciences Equipment & Trading, LLC · Jun 2017
Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
K170270 · Ls Scientific Inc. D.B.A. Kse Scientific · Jun 2017
Ross Ru Wound Dressing Gel
K162017 · Biotd S.A. · Apr 2017
LUOFUCON Silicone Ag Foam Dressing with Border
K170077 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2017
ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
K163529 · Avery Dennison Corporation · Mar 2017