Stasis Gel
K-Number: K211420 · 2022-03-14
ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2022-03-14
Product CodeMVL
DecisionSubstantially Equivalent
Device Summary
Stasis Gel is a medical device manufactured by Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2022-03-14 under approval number K211420. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Stasis Gel?
Stasis Gel is a medical device that received FDA 510(k) clearance on 2022-03-14. It is manufactured by Belport Company, Inc., Gingi-Pak. The 510(k) number is K211420.
When was Stasis Gel approved by the FDA?
Stasis Gel received FDA 510(k) clearance on 2022-03-14, under approval number K211420.
What company makes Stasis Gel?
Stasis Gel is manufactured by Belport Company, Inc., Gingi-Pak.
What is the FDA product code for Stasis Gel?
The FDA product code for Stasis Gel is MVL.
Other Devices by Belport Company, Inc., Gingi-Pak
Related Devices (Code: MVL)
K162662GingiDent Gingival Retraction PastePac-Dent International, Inc.
K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsKerr Corporation
K162536GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction CordKerr Corporation
K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordKerr Corporation
K171577Smartcord, Smartcord XEastdent Co., Ltd.
K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products
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.