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FDA 510(k)

SEILER COLPOSCOPE, MODELS 935, 955 AND 985

K-Number: K101141 · 2010-08-06

ApplicantSeiler Precision Microscopes
Decision Date2010-08-06
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SEILER COLPOSCOPE, MODELS 935, 955 AND 985 is the device name listed in this FDA 510(k) record. The listed applicant is Seiler Precision Microscopes. It received FDA 510(k) clearance on 2010-08-06 under 510(k) number K101141. 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 SEILER COLPOSCOPE, MODELS 935, 955 AND 985?

SEILER COLPOSCOPE, MODELS 935, 955 AND 985 is a medical device that received FDA 510(k) clearance on 2010-08-06. The listed applicant is Seiler Precision Microscopes. The 510(k) number is K101141.

When did SEILER COLPOSCOPE, MODELS 935, 955 AND 985 receive FDA 510(k) clearance?

SEILER COLPOSCOPE, MODELS 935, 955 AND 985 received FDA 510(k) clearance on 2010-08-06, under 510(k) number K101141.

Who is the listed applicant for SEILER COLPOSCOPE, MODELS 935, 955 AND 985?

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

What is the FDA product code for SEILER COLPOSCOPE, MODELS 935, 955 AND 985?

The FDA product code for SEILER COLPOSCOPE, MODELS 935, 955 AND 985 is HEX.

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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

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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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