Cleared Traditional

K161623 - Prontosan Wound Irrigation Solution

K161623 · B.Braun Medical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2016
Decision
150d
Days
-
Risk

K161623 is an FDA 510(k) clearance for the Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Soluti.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 10, 2016 after a review of 150 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 - K161623

510(k) Number K161623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2016
Decision Date November 10, 2016
Days to Decision 150 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
35d slower than avg
Panel avg: 115d · This submission: 150d
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 260
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K161623.
Catasyn Advanced Technology Wound Hydrogel
K172338 · Synedgen, Inc. · Feb 2018
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
LUOFUCON Silicone Ag Foam Dressing with Border
K170077 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2017
ACTICOAT Surgical Dressing
K153723 · Smith & Nephew Medical Limited · Sep 2016
Exufiber Ag+
K160379 · Molnlycke Health Care Us, LLC · Aug 2016
LUOFUCON Silicone Ag foam dressing
K160022 · Huizhou Foryou Medical Devices Co., Ltd. · Aug 2016