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FDA 510(k)

CYSTOSCOPE

K-Number: K941992 · 1995-11-30

ApplicantSurgical Technologies, Inc.
Decision Date1995-11-30
Product CodeFBO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYSTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1995-11-30 under 510(k) number K941992. 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 CYSTOSCOPE?

CYSTOSCOPE is a medical device that received FDA 510(k) clearance on 1995-11-30. The listed applicant is Surgical Technologies, Inc.. The 510(k) number is K941992.

When did CYSTOSCOPE receive FDA 510(k) clearance?

CYSTOSCOPE received FDA 510(k) clearance on 1995-11-30, under 510(k) number K941992.

Who is the listed applicant for CYSTOSCOPE?

The FDA 510(k) record lists Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYSTOSCOPE?

The FDA product code for CYSTOSCOPE is FBO.

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Other records listing Surgical Technologies, Inc. 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.

K942029ARTHROSCOPEK946136INFINITECH LIGHTED INFUSION CANNULAK952566OSCILFLATORK951918SURGICAL TECHNOLOGIES, INC. SYRINGEK950683ARTHROGRAM TRAYK946135INFINITECH ASPIRATING LASER PROBE

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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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