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FDA 510(k)

COLONGLIDE(R) LUBRICANT

K-Number: K131617 · 2013-10-03

ApplicantPediatric Pharmaceuticals, Inc.
Decision Date2013-10-03
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COLONGLIDE(R) LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Pediatric Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2013-10-03 under 510(k) number K131617. 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 COLONGLIDE(R) LUBRICANT?

COLONGLIDE(R) LUBRICANT is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Pediatric Pharmaceuticals, Inc.. The 510(k) number is K131617.

When did COLONGLIDE(R) LUBRICANT receive FDA 510(k) clearance?

COLONGLIDE(R) LUBRICANT received FDA 510(k) clearance on 2013-10-03, under 510(k) number K131617.

Who is the listed applicant for COLONGLIDE(R) LUBRICANT?

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

What is the FDA product code for COLONGLIDE(R) LUBRICANT?

The FDA product code for COLONGLIDE(R) LUBRICANT is KMJ.

Related Clinical Trials

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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.

K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal CorporationK092488DYNAREX STERILE LUBRICATING JELLYDynarex 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.

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