FDA 510(k)

KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM

K-Number: K062918 · 2007-01-17

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date2007-01-17

Product CodeFBO

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2007-01-17 under 510(k) number K062918. 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 KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM?

KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-17. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K062918.

When did KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM receive FDA 510(k) clearance?

KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM received FDA 510(k) clearance on 2007-01-17, under 510(k) number K062918.

Who is the listed applicant for KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM?

The FDA product code for KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM is FBO.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System K223923HOPKINS Telescopes

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Related Devices (Code: FBO)

K244001KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)Karl Storz SE & CO. KG K243409KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)Karl Storz SE & CO. KG K082046KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCOKARL STORZ Endoscopy-America, Inc.K080780ANCHORAGE SCOPE, MODEL 000003Epitek, Inc.K061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESLaserscope K011496CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660Richard Wolf Medical Instruments Corp.

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.