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FDA 510(k)

OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE

K-Number: K860858 · 1986-11-20

ApplicantOlympus Corp.
Decision Date1986-11-20
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1986-11-20 under 510(k) number K860858. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE?

OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE is a medical device that received FDA 510(k) clearance on 1986-11-20. The listed applicant is Olympus Corp.. The 510(k) number is K860858.

When did OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE receive FDA 510(k) clearance?

OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE received FDA 510(k) clearance on 1986-11-20, under 510(k) number K860858.

Who is the listed applicant for OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE?

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 PF-18 & PF-25 ULTRATHIN ANGIOSCOPE?

The FDA product code for OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE is LYK.

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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: LYK)

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.

K253842Vena MicroAngioscope™ SystemVena Medical Holdings CorpK251767Vena MicroAngioscope™ SystemVena Medical Holdings CorpK062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCardio-Optics, Inc.K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.K012724SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, Inc.

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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