Cleared Traditional

K193336 - Synvaza Mouth Sore and Wound Rinse

K193336 · Synedgen, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
177d
Days
-
Risk

K193336 is an FDA 510(k) clearance for the Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse. Classified as Oral Wound Dressing (product code OLR).

Submitted by Synedgen, Inc. (Claremont, US). The FDA issued a Cleared decision on May 27, 2020 after a review of 177 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 K193336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2019
Decision Date May 27, 2020
Days to Decision 177 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 13
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K193336.
PuraStat-OM
K210211 · 3-D Matrix, Inc. · Oct 2021
MucoLock Oral Gel
K203091 · Pcca, Inc. · Feb 2021
Silatrix Oral Gel
K202000 · Sa3, LLC · Nov 2020
Orapeutic
K191987 · Forward Science · Nov 2019
OraCure
K183436 · Tbm Corporation · Sep 2019
SUNTOUCH Dental Dressing
K173196 · Huizhou Foryou Medical Devices Co., Ltd. · Jan 2018