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FDA 510(k)

LEISEGANG VIDEO COLPOSCOPE

K-Number: K981958 · 1998-10-19

ApplicantNetoptix Corp.
Decision Date1998-10-19
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LEISEGANG VIDEO COLPOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Netoptix Corp.. It received FDA 510(k) clearance on 1998-10-19 under 510(k) number K981958. 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 LEISEGANG VIDEO COLPOSCOPE?

LEISEGANG VIDEO COLPOSCOPE is a medical device that received FDA 510(k) clearance on 1998-10-19. The listed applicant is Netoptix Corp.. The 510(k) number is K981958.

When did LEISEGANG VIDEO COLPOSCOPE receive FDA 510(k) clearance?

LEISEGANG VIDEO COLPOSCOPE received FDA 510(k) clearance on 1998-10-19, under 510(k) number K981958.

Who is the listed applicant for LEISEGANG VIDEO COLPOSCOPE?

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

What is the FDA product code for LEISEGANG VIDEO COLPOSCOPE?

The FDA product code for LEISEGANG VIDEO COLPOSCOPE is HEX.

Related Clinical Trials

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Other records listing Netoptix 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.

K981828GALILEO DISPOSABLE HYSTEROSCOPESK974297GALILEO DISPOSABLE HYSTEROSCOPESK971896GALILEO HIGH RESOLUTION MICRO COUPLER

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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