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FDA 510(k)

Miniature Telescope for Urology (27033AA)

K-Number: K253411 · 2025-11-18

ApplicantKarl Storz SE & CO. KG
Decision Date2025-11-18
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Miniature Telescope for Urology (27033AA) 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 2025-11-18 under 510(k) number K253411. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miniature Telescope for Urology (27033AA)?

Miniature Telescope for Urology (27033AA) is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K253411.

When did Miniature Telescope for Urology (27033AA) receive FDA 510(k) clearance?

Miniature Telescope for Urology (27033AA) received FDA 510(k) clearance on 2025-11-18, under 510(k) number K253411.

Who is the listed applicant for Miniature Telescope for Urology (27033AA)?

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 Miniature Telescope for Urology (27033AA)?

The FDA product code for Miniature Telescope for Urology (27033AA) is FGB.

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: FGB)

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.

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.K260013CVAC Image ProcessorCalyxo, Inc.K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument Co., Ltd.

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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