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FDA 510(k)

CO-1000 COLPOSCOPE, MULTIPLE

K-Number: K061306 · 2006-08-07

ApplicantGynex Corp.
Decision Date2006-08-07
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CO-1000 COLPOSCOPE, MULTIPLE is the device name listed in this FDA 510(k) record. The listed applicant is Gynex Corp.. It received FDA 510(k) clearance on 2006-08-07 under 510(k) number K061306. 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 CO-1000 COLPOSCOPE, MULTIPLE?

CO-1000 COLPOSCOPE, MULTIPLE is a medical device that received FDA 510(k) clearance on 2006-08-07. The listed applicant is Gynex Corp.. The 510(k) number is K061306.

When did CO-1000 COLPOSCOPE, MULTIPLE receive FDA 510(k) clearance?

CO-1000 COLPOSCOPE, MULTIPLE received FDA 510(k) clearance on 2006-08-07, under 510(k) number K061306.

Who is the listed applicant for CO-1000 COLPOSCOPE, MULTIPLE?

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

What is the FDA product code for CO-1000 COLPOSCOPE, MULTIPLE?

The FDA product code for CO-1000 COLPOSCOPE, MULTIPLE is HEX.

Related Clinical Trials

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Other records listing Gynex Corp. 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.

K982739GYNEX ELECTRODESK980238GYNEX EXTENDED REACH NEEDLEK980237GYNEX ENDOSPECULUMK980247GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM

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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