KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) (K251731): 510(k) cleared Dec 5, 2025

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

Karl Storz SE & CO. KG · Dec 5, 2025 · K251731

FDA cleared the KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) from Karl Storz SE & CO. KG on Dec 5, 2025 under K251731, a special 510(k). The device falls under product code EOQ, Bronchoscope (Flexible Or Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Jun 6, 2025. The decision came 182 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Karl Storz SE & CO. KG has 8 other decisions in the tracker over the last 12 months: K254252 (UNIDRIVE 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)), K254303 (KARL STORZ SUPRALOOP), K261102 (UNIDRIVE Select System), K254299 (CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)).

Questions & Answers

What did FDA clear under K251731?

K251731 is the FDA 510(k) for KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612), submitted by Karl Storz SE & CO. KG. FDA's decision date was Dec 5, 2025, under product code EOQ (Bronchoscope (Flexible Or Rigid)).

Who makes the KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K251731.

How long did the K251731 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Dec 5, 2025, 182 days later.

← All decisions in December 2025