Cleared Traditional

K172338 - Catasyn Advanced Technology Wound Hydrogel

K172338 · Synedgen, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
203d
Days
-
Risk

K172338 is an FDA 510(k) clearance for the Catasyn Advanced Technology Wound Hydrogel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Synedgen, Inc. (Claremont, US). The FDA issued a Cleared decision on February 21, 2018 after a review of 203 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 Synedgen, Inc. devices

Submission Details

510(k) Number K172338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2017
Decision Date February 21, 2018
Days to Decision 203 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
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 211
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K172338.
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
K180305 · Aquilabs Us, LLC · Apr 2018
Algidex Ag Silver Alginate Wound Dressing
K173072 · Deroyal Industries, Inc. · Apr 2018
Microcyn Antimicrobial Hydrogel
K173896 · Sonoma Pharmaceuticals, Inc. · Apr 2018
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016
PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013