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FDA 510(k)

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

K-Number: K251731 · 2025-12-05

ApplicantKarl Storz SE & CO. KG
Decision Date2025-12-05
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) 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 2025-12-05 under 510(k) number K251731. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)?

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K251731.

When did KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) receive FDA 510(k) clearance?

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K251731.

Who is the listed applicant for KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)?

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 Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)?

The FDA product code for KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) is EOQ.

Related Clinical Trials

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.

NCT05902013Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal IntubationCOMPLETEDNCT05967507Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2)RECRUITINGNCT07353255Fibrescope vs Videolaryngoscope for Nasotracheal IntubationRECRUITINGNCT07577648Channelled Blade Versus Non-Channelled VideolaryngoscopeACTIVE_NOT_RECRUITING

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: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology 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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