FDA 510(k)

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

Numéro K : K251731 · 2025-12-05

Date de décision2025-12-05

Code produitEOQ

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Karl Storz SE & CO. KG en tant que demandeur

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)K254303KARL STORZ SUPRALOOP K261102UNIDRIVE Select System K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)K260884UNIDRIVE Select System K254103HOPKINS Telescopes for Arthroscopy

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Dispositifs connexes (Code : EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Source officielle

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