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FDA 510(k)

COLPOSCOPES AND ACCESSORIES

K-Number: K940094 · 1995-04-25

ApplicantLeisegang Medical, Inc.
Decision Date1995-04-25
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COLPOSCOPES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Leisegang Medical, Inc.. It received FDA 510(k) clearance on 1995-04-25 under 510(k) number K940094. 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 COLPOSCOPES AND ACCESSORIES?

COLPOSCOPES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Leisegang Medical, Inc.. The 510(k) number is K940094.

When did COLPOSCOPES AND ACCESSORIES receive FDA 510(k) clearance?

COLPOSCOPES AND ACCESSORIES received FDA 510(k) clearance on 1995-04-25, under 510(k) number K940094.

Who is the listed applicant for COLPOSCOPES AND ACCESSORIES?

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

What is the FDA product code for COLPOSCOPES AND ACCESSORIES?

The FDA product code for COLPOSCOPES AND ACCESSORIES is HEX.

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Other records listing Leisegang Medical, 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.

K990043SMOOTHLASE ALEXANDRITE LASER SYSTEMK924134LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESSK920217MAX-E-VACK914201LM- LAP 10 HIGH FLOW INSUFFLATORK912789LM-100/200LOW FLOW INSUFFLATORK913135LM-300TWIN

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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.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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