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FDA 510(k)

OCS-2 COLPOSCOPE

K-Number: K852980 · 1985-10-23

ApplicantOlympus Corp.
Decision Date1985-10-23
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OCS-2 COLPOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1985-10-23 under 510(k) number K852980. 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 OCS-2 COLPOSCOPE?

OCS-2 COLPOSCOPE is a medical device that received FDA 510(k) clearance on 1985-10-23. The listed applicant is Olympus Corp.. The 510(k) number is K852980.

When did OCS-2 COLPOSCOPE receive FDA 510(k) clearance?

OCS-2 COLPOSCOPE received FDA 510(k) clearance on 1985-10-23, under 510(k) number K852980.

Who is the listed applicant for OCS-2 COLPOSCOPE?

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

What is the FDA product code for OCS-2 COLPOSCOPE?

The FDA product code for OCS-2 COLPOSCOPE is HEX.

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Other records listing Olympus 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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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