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FDA 510(k)

Barrigel Injectable Gel

K-Number: K220641 · 2022-05-26

ApplicantPalette Life Sciences
Decision Date2022-05-26
Product CodeOVB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Barrigel Injectable Gel is a medical device manufactured by Palette Life Sciences. It received FDA 510(k) clearance on 2022-05-26 under approval number K220641. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Barrigel Injectable Gel?

Barrigel Injectable Gel is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by Palette Life Sciences. The 510(k) number is K220641.

When was Barrigel Injectable Gel approved by the FDA?

Barrigel Injectable Gel received FDA 510(k) clearance on 2022-05-26, under approval number K220641.

What company makes Barrigel Injectable Gel?

Barrigel Injectable Gel is manufactured by Palette Life Sciences.

What is the FDA product code for Barrigel Injectable Gel?

The FDA product code for Barrigel Injectable Gel is OVB.

Other Devices by Palette Life Sciences

PMA P000029AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE PMA P100014AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

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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.

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