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FDA 510(k)

Flexible Intubation Video Endoscope – Sterile (FIVE-S)

K-Number: K212656 · 2021-12-29

ApplicantKarl Storz Endoscopy America
Decision Date2021-12-29
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2021-12-29 under 510(k) number K212656. 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 Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is a medical device that received FDA 510(k) clearance on 2021-12-29. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K212656.

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

Flexible Intubation Video Endoscope – Sterile (FIVE-S) received FDA 510(k) clearance on 2021-12-29, under 510(k) number K212656.

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

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

What is the FDA product code for Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

The FDA product code for Flexible Intubation Video Endoscope – Sterile (FIVE-S) 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.

NCT06981923Awake Video Stylet Airway Assessment and Evaluation of Tracheal Intubation With CMAC D-Blade Versus Video Stylet in Bariatric SurgeryCOMPLETEDNCT07353255Fibrescope vs Videolaryngoscope for Nasotracheal IntubationRECRUITING

Other records listing Karl Storz Endoscopy America 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.

PMA P050027Light source system, diagnostic endoscopicK252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH 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

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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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