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FDA 510(k)

AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE

K-Number: K122973 · 2013-06-12

ApplicantMedgyn Products, Inc.
Decision Date2013-06-12
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Medgyn Products, Inc.. It received FDA 510(k) clearance on 2013-06-12 under 510(k) number K122973. 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 AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE?

AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE is a medical device that received FDA 510(k) clearance on 2013-06-12. The listed applicant is Medgyn Products, Inc.. The 510(k) number is K122973.

When did AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE receive FDA 510(k) clearance?

AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE received FDA 510(k) clearance on 2013-06-12, under 510(k) number K122973.

Who is the listed applicant for AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE?

The FDA 510(k) record lists Medgyn Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE?

The FDA product code for AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE is HEX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medgyn Products, Inc. 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.

K945179BOTTLE COLLECTION SETK880196LAMINARIAK880195GYNESCOPE

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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