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FDA 510(k)

CERVICAL MD, MODEL C10

K-Number: K072691 · 2008-01-31

ApplicantSti Medical Systems
Decision Date2008-01-31
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERVICAL MD, MODEL C10 is the device name listed in this FDA 510(k) record. The listed applicant is Sti Medical Systems. It received FDA 510(k) clearance on 2008-01-31 under 510(k) number K072691. 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 CERVICAL MD, MODEL C10?

CERVICAL MD, MODEL C10 is a medical device that received FDA 510(k) clearance on 2008-01-31. The listed applicant is Sti Medical Systems. The 510(k) number is K072691.

When did CERVICAL MD, MODEL C10 receive FDA 510(k) clearance?

CERVICAL MD, MODEL C10 received FDA 510(k) clearance on 2008-01-31, under 510(k) number K072691.

Who is the listed applicant for CERVICAL MD, MODEL C10?

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

What is the FDA product code for CERVICAL MD, MODEL C10?

The FDA product code for CERVICAL MD, MODEL C10 is HEX.

Related Clinical Trials

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Other records listing Sti Medical Systems 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.

K090324ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY

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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