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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 the device name listed in this FDA 510(k) record. The listed applicant is Palette Life Sciences. It received FDA 510(k) clearance on 2022-05-26 under 510(k) 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. The listed applicant is Palette Life Sciences. The 510(k) number is K220641.

When did Barrigel Injectable Gel receive FDA 510(k) clearance?

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

Who is the listed applicant for Barrigel Injectable Gel?

The FDA 510(k) record lists Palette Life Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Barrigel Injectable Gel?

The FDA product code for Barrigel Injectable Gel is OVB.

Other records listing Palette Life Sciences as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: OVB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260119SpaceOAR Vue System (SV-2101)Boston Scientific CorporationK222972BioProtect Balloon Implant™ SystemBioprotect, Ltd.K202224SpaceOAR SystemBoston Scientific CorporationK182971SpaceOAR Vue HydrogelAugmenix, Inc.K181465SpaceOAR SystemAugmenix, 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.

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