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FDA 510(k)

Colposcope System

K-Number: K160341 · 2016-09-14

ApplicantXuzhou Kernel Medical Equipment Co., Ltd.
Decision Date2016-09-14
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Colposcope System is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K160341. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Colposcope System?

Colposcope System is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K160341.

When did Colposcope System receive FDA 510(k) clearance?

Colposcope System received FDA 510(k) clearance on 2016-09-14, under 510(k) number K160341.

Who is the listed applicant for Colposcope System?

The FDA 510(k) record lists Xuzhou Kernel Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Colposcope System?

The FDA product code for Colposcope System is HEX.

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Related Devices (Code: HEX)

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.

K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd.K190187Gynescope SystemIllumigyn , Ltd.K182764Biop Digital ColposcopeBiop Medical , Ltd.K181034Pocket Colposcope SystemHadleigh Health Technologies, LLCK170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.

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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