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FDA 510(k)

ENDOSCOPIC APPLICATOR

K-Number: K120608 · 2012-03-15

ApplicantMicromedics, Inc.
Decision Date2012-03-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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 2012-03-15 under 510(k) number K120608. 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 ENDOSCOPIC APPLICATOR?

ENDOSCOPIC APPLICATOR is a medical device that received FDA 510(k) clearance on 2012-03-15. The listed applicant is Micromedics, Inc.. The 510(k) number is K120608.

When did ENDOSCOPIC APPLICATOR receive FDA 510(k) clearance?

ENDOSCOPIC APPLICATOR received FDA 510(k) clearance on 2012-03-15, under 510(k) number K120608.

Who is the listed applicant for 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 ENDOSCOPIC APPLICATOR?

The FDA product code for ENDOSCOPIC APPLICATOR is GCJ.

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Other records listing Micromedics, Inc. as applicant

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Related Devices (Code: GCJ)

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Official Source

View on FDA Database →

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

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