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FDA 510(k)

Biop Digital Colposcope

K-Number: K182764 · 2018-11-27

ApplicantBiop Medical , Ltd.
Decision Date2018-11-27
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Biop Digital Colposcope is the device name listed in this FDA 510(k) record. The listed applicant is Biop Medical , Ltd.. It received FDA 510(k) clearance on 2018-11-27 under 510(k) number K182764. 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 Biop Digital Colposcope?

Biop Digital Colposcope is a medical device that received FDA 510(k) clearance on 2018-11-27. The listed applicant is Biop Medical , Ltd.. The 510(k) number is K182764.

When did Biop Digital Colposcope receive FDA 510(k) clearance?

Biop Digital Colposcope received FDA 510(k) clearance on 2018-11-27, under 510(k) number K182764.

Who is the listed applicant for Biop Digital Colposcope?

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

What is the FDA product code for Biop Digital Colposcope?

The FDA product code for Biop Digital Colposcope is HEX.

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.K181034Pocket Colposcope SystemHadleigh Health Technologies, LLCK170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., 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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