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FDA 510(k)

FLEXIBLE AND RIGID URETEROTOME SYSTEM

K-Number: K904939 · 1992-01-07

ApplicantOlympus Corp.
Decision Date1992-01-07
Product CodeEZO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE AND RIGID URETEROTOME SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1992-01-07 under 510(k) number K904939. The device is classified under product code EZO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE AND RIGID URETEROTOME SYSTEM?

FLEXIBLE AND RIGID URETEROTOME SYSTEM is a medical device that received FDA 510(k) clearance on 1992-01-07. The listed applicant is Olympus Corp.. The 510(k) number is K904939.

When did FLEXIBLE AND RIGID URETEROTOME SYSTEM receive FDA 510(k) clearance?

FLEXIBLE AND RIGID URETEROTOME SYSTEM received FDA 510(k) clearance on 1992-01-07, under 510(k) number K904939.

Who is the listed applicant for FLEXIBLE AND RIGID URETEROTOME SYSTEM?

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 FLEXIBLE AND RIGID URETEROTOME SYSTEM?

The FDA product code for FLEXIBLE AND RIGID URETEROTOME SYSTEM is EZO.

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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: EZO)

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.

K000905URETHROTOME 8667.XXX AND 8670.XXXRichard Wolf Medical Instruments Corp.K950719OES UROLOGYOlympus America, Inc.K945686KARL STORZ KNIVES, CURETTESKARL STORZ Endoscopy-America, Inc.K934730KARL STORZ ENDOSCOPIC COLD KNIFE BLADESKARL STORZ Endoscopy-America, 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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