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FDA 510(k)

Pocket Colposcope System

K-Number: K181034 · 2018-09-21

ApplicantHadleigh Health Technologies, LLC
Decision Date2018-09-21
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Pocket Colposcope System is the device name listed in this FDA 510(k) record. The listed applicant is Hadleigh Health Technologies, LLC. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K181034. 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 Pocket Colposcope System?

Pocket Colposcope System is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Hadleigh Health Technologies, LLC. The 510(k) number is K181034.

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

Pocket Colposcope System received FDA 510(k) clearance on 2018-09-21, under 510(k) number K181034.

Who is the listed applicant for Pocket Colposcope System?

The FDA 510(k) record lists Hadleigh Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pocket Colposcope System?

The FDA product code for Pocket Colposcope System is HEX.

Other records listing Hadleigh Health Technologies, LLC 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: 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.K170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd.

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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