FDA 510(k)

GELX ORAL GEL

K-Number: K081372 · 2009-02-04

Decision Date2009-02-04

Product CodeOLR

DecisionSubstantially Equivalent

Device Summary

GELX ORAL GEL is the device name listed in this FDA 510(k) record. The listed applicant is Bmg Pharma, LLC. It received FDA 510(k) clearance on 2009-02-04 under 510(k) number K081372. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELX ORAL GEL?

GELX ORAL GEL is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Bmg Pharma, LLC. The 510(k) number is K081372.

When did GELX ORAL GEL receive FDA 510(k) clearance?

GELX ORAL GEL received FDA 510(k) clearance on 2009-02-04, under 510(k) number K081372.

Who is the listed applicant for GELX ORAL GEL?

The FDA 510(k) record lists Bmg Pharma, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GELX ORAL GEL?

The FDA product code for GELX ORAL GEL is OLR.

Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLC K251908Emanate TrayEmanate Biomedical K260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

Official Source

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