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FDA 510(k)

OLYMPUS FLEXIBLE TIP THORACOSCOPE

K-Number: K913829 · 1991-11-22

ApplicantOlympus Corp.
Decision Date1991-11-22
Product CodeEWY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OLYMPUS FLEXIBLE TIP THORACOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K913829. The device is classified under product code EWY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS FLEXIBLE TIP THORACOSCOPE?

OLYMPUS FLEXIBLE TIP THORACOSCOPE is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Olympus Corp.. The 510(k) number is K913829.

When did OLYMPUS FLEXIBLE TIP THORACOSCOPE receive FDA 510(k) clearance?

OLYMPUS FLEXIBLE TIP THORACOSCOPE received FDA 510(k) clearance on 1991-11-22, under 510(k) number K913829.

Who is the listed applicant for OLYMPUS FLEXIBLE TIP THORACOSCOPE?

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 OLYMPUS FLEXIBLE TIP THORACOSCOPE?

The FDA product code for OLYMPUS FLEXIBLE TIP THORACOSCOPE is EWY.

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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: EWY)

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.

K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KGK213194HD MediastinoscopeKarl Storz Endoscopy America, Inc.K202272HD MediastinoscopeKarl Storz Endoscopy America, Inc.K170757Aegis Transit SystemBoston-Biomedical AssociatesK160171Illuminated Mediastinal Access PortAegis Surgical, Ltd.K971166OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECERichard Wolf Medical Instruments Corp.

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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