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FDA 510(k)

MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR

K-Number: K042834 · 2005-02-11

Decision Date2005-02-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc.. It received FDA 510(k) clearance on 2005-02-11 under 510(k) number K042834. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR?

MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Micromedics, Inc.. The 510(k) number is K042834.

When did MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR receive FDA 510(k) clearance?

MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR received FDA 510(k) clearance on 2005-02-11, under 510(k) number K042834.

Who is the listed applicant for MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR?

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

What is the FDA product code for MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR?

The FDA product code for MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR is GCJ.

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.

Other records listing Micromedics, 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.

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Related Devices (Code: GCJ)

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.

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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