Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse— 510(k) K193336

Name: FDA 510(k) clearance K193336
Creator: U.S. Food and Drug Administration
Published: 2020-05-27

Substantially Equivalent

Synedgen, Inc.

FDA 510(k) clearance K193336 for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse, Substantially Equivalent on 2020-05-27. Applicant: Synedgen, Inc.. Device class: Unclassified.

Clearance details

Applicant: Synedgen, Inc.
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2019-12-02
Decision date: 2020-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

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K260120 — NaturaJel Oral Wound Care Kit2026-08-05
K251908 — Emanate Tray2026-07-29
K260126 — Curajel Oral Gel2026-06-15
K253816 — MuCover (proposed name) Oral Wound Dressing2026-05-21
K253758 — Dental Cone; Dental Sponge2025-12-18

More clearances from Synedgen, Inc.

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K172338 — Catasyn Advanced Technology Wound Hydrogel2018-02-21
K143444 — SynePure Wound Cleanser2015-08-21

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.