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FDA 510(k)

CONTINUOUS IRRIGATION CYSTOURETHROSCOPE

K-Number: K935163 · 1994-09-07

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1994-09-07
Product CodeFBO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS IRRIGATION CYSTOURETHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1994-09-07 under 510(k) number K935163. The device is classified under product code FBO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUOUS IRRIGATION CYSTOURETHROSCOPE?

CONTINUOUS IRRIGATION CYSTOURETHROSCOPE is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K935163.

When did CONTINUOUS IRRIGATION CYSTOURETHROSCOPE receive FDA 510(k) clearance?

CONTINUOUS IRRIGATION CYSTOURETHROSCOPE received FDA 510(k) clearance on 1994-09-07, under 510(k) number K935163.

Who is the listed applicant for CONTINUOUS IRRIGATION CYSTOURETHROSCOPE?

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

What is the FDA product code for CONTINUOUS IRRIGATION CYSTOURETHROSCOPE?

The FDA product code for CONTINUOUS IRRIGATION CYSTOURETHROSCOPE is FBO.

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Other records listing Richard Wolf Medical Instruments Corp. as applicant

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Related Devices (Code: FBO)

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.

K244001KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)Karl Storz SE & CO. KGK243409KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)Karl Storz SE & CO. KGK082046KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCOKARL STORZ Endoscopy-America, Inc.K080780ANCHORAGE SCOPE, MODEL 000003Epitek, Inc.K062918KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEMKARL STORZ Endoscopy-America, Inc.K061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESLaserscope

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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