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FDA 510(k)

BUTTON LUBRICATOR

K-Number: K951713 · 1995-04-25

ApplicantFibertech Instruments, Inc.
Decision Date1995-04-25
Product CodeFHX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BUTTON LUBRICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Fibertech Instruments, Inc.. It received FDA 510(k) clearance on 1995-04-25 under 510(k) number K951713. The device is classified under product code FHX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUTTON LUBRICATOR?

BUTTON LUBRICATOR is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Fibertech Instruments, Inc.. The 510(k) number is K951713.

When did BUTTON LUBRICATOR receive FDA 510(k) clearance?

BUTTON LUBRICATOR received FDA 510(k) clearance on 1995-04-25, under 510(k) number K951713.

Who is the listed applicant for BUTTON LUBRICATOR?

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

What is the FDA product code for BUTTON LUBRICATOR?

The FDA product code for BUTTON LUBRICATOR is FHX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fibertech Instruments, Inc. 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.

K940780SCOPEJOCKEY

Related Devices (Code: FHX)

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.

K081990LUBRICANO STERILE GELFarco Pharma GmbHK935548CATHEJELL S STERILE LUBRICATING JELLYPharmazeutische Fabrik Montavit GmbHK912132OPERAND LUBRICATING JELLYGeneral Medical Co.K780386K-Y LUBRICATING JELLYJohnson & Johnson Professionals, Inc.K771364LUBE JELTravenol Laboratories, S.A.

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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