Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse

K-Number: K193336 · 2020-05-27

ApplicantSynedgen, Inc.
Decision Date2020-05-27
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is a medical device manufactured by Synedgen, Inc.. It received FDA 510(k) clearance on 2020-05-27 under approval number K193336. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is a medical device that received FDA 510(k) clearance on 2020-05-27. It is manufactured by Synedgen, Inc.. The 510(k) number is K193336.

When was Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse approved by the FDA?

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse received FDA 510(k) clearance on 2020-05-27, under approval number K193336.

What company makes Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is manufactured by Synedgen, Inc..

What is the FDA product code for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse?

The FDA product code for Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse is OLR.

Related Clinical Trials

NCT07551297 Ozone Therapy After Open Flap Debridement in Periodontitis COMPLETED NCT05401201 Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP COMPLETED NCT07520266 Gingival Depigmentation With Diode and Er,Cr:YSGG Laser: A Split-mouth Trial COMPLETED NCT07321704 Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease RECRUITING

Other Devices by Synedgen, Inc.

K172338Catasyn Advanced Technology Wound Hydrogel

Related Devices (Code: OLR)

K173196SUNTOUCH Dental DressingHuizhou Foryou Medical Devices Co., Ltd. K191987OrapeuticForward Science K183436OraCureTbm Corporation K202000Silatrix Oral GelSa3, LLC K210211PuraStat-OM3-D Matrix, Inc. K203091MucoLock Oral GelPcca, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑