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FDA 510(k)

COLPOSCOPE MODEL II

K-Number: K770896 · 1977-06-03

ApplicantDynatech Cryomedical Co.
Decision Date1977-06-03
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COLPOSCOPE MODEL II is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Cryomedical Co.. It received FDA 510(k) clearance on 1977-06-03 under 510(k) number K770896. 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 MODEL II?

COLPOSCOPE MODEL II is a medical device that received FDA 510(k) clearance on 1977-06-03. The listed applicant is Dynatech Cryomedical Co.. The 510(k) number is K770896.

When did COLPOSCOPE MODEL II receive FDA 510(k) clearance?

COLPOSCOPE MODEL II received FDA 510(k) clearance on 1977-06-03, under 510(k) number K770896.

Who is the listed applicant for COLPOSCOPE MODEL II?

The FDA 510(k) record lists Dynatech Cryomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLPOSCOPE MODEL II?

The FDA product code for COLPOSCOPE MODEL II is HEX.

Related Clinical Trials

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Other records listing Dynatech Cryomedical Co. 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.

K771898AUTOMATED SLIDE SPINNERK771815SIGMOSCOPEK770614MONITOR, GAS MANIFOLDK761205DYNATECH JD7/JD7P COLPOSCOPEK760763COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I

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

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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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