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FDA 510(k)

SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)

K-Number: K904797 · 1991-03-05

ApplicantSurgitek
Decision Date1991-03-05
Product CodeFBO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1991-03-05 under 510(k) number K904797. 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 SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)?

SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is Surgitek. The 510(k) number is K904797.

When did SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) receive FDA 510(k) clearance?

SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) received FDA 510(k) clearance on 1991-03-05, under 510(k) number K904797.

Who is the listed applicant for SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)?

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

What is the FDA product code for SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)?

The FDA product code for SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16) is FBO.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933261GRASPING FORCEPSK933260HELICAL STONE/FLATWIRE STONE BASKETS

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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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