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FDA 510(k)

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)

K-Number: K243409 · 2024-11-27

ApplicantKarl Storz SE & CO. KG
Decision Date2024-11-27
Product CodeFBO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K243409. 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 Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K243409.

When did KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) receive FDA 510(k) clearance?

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K243409.

Who is the listed applicant for KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

The FDA product code for KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is FBO.

Other records listing Karl Storz SE & CO. KG 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.

K261706Endomat Select (UP220)K252800KARL STORZ Endoscopic Accessories for UrologyK254228KARL STORZ Trocars with Valve SealsK260003KARL STORZ Mediastinoscopes and InstrumentsK254242KARL STORZ ICG Imaging System with RUBINA® LensK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)

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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. KG

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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