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FDA 510(k)

RESECTOSCOPE SHEATH

K-Number: K931995 · 1993-07-23

ApplicantOlympus Corp.
Decision Date1993-07-23
Product CodeFJL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RESECTOSCOPE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1993-07-23 under 510(k) number K931995. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESECTOSCOPE SHEATH?

RESECTOSCOPE SHEATH is a medical device that received FDA 510(k) clearance on 1993-07-23. The listed applicant is Olympus Corp.. The 510(k) number is K931995.

When did RESECTOSCOPE SHEATH receive FDA 510(k) clearance?

RESECTOSCOPE SHEATH received FDA 510(k) clearance on 1993-07-23, under 510(k) number K931995.

Who is the listed applicant for RESECTOSCOPE SHEATH?

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 RESECTOSCOPE SHEATH?

The FDA product code for RESECTOSCOPE SHEATH is FJL.

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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: FJL)

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.

K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KGK221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.K230205Veloxion SystemCorinth Medtech, Inc.K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc.K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc.K162979Veloxion SystemCorinth Medtech, 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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