FDA 510(k)

K-GEL

K-Number: K872128 · 1987-06-12

Decision Date1987-06-12

Product CodeKMJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

K-GEL is the device name listed in this FDA 510(k) record. The listed applicant is Taro Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1987-06-12 under 510(k) number K872128. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-GEL?

K-GEL is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Taro Pharmaceuticals, Inc.. The 510(k) number is K872128.

When did K-GEL receive FDA 510(k) clearance?

K-GEL received FDA 510(k) clearance on 1987-06-12, under 510(k) number K872128.

Who is the listed applicant for K-GEL?

The FDA 510(k) record lists Taro Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-GEL?

The FDA product code for K-GEL is KMJ.

Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal Corporation K112110STERILE LUBRICATING JELLYJianerkang Medical Dressing Company K103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal Corporation

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.