WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid

The Tracker / September 2026 / K260884

510(k) cleared

UNIDRIVE Select System

Karl Storz SE & CO. KG · Sep 1, 2026 · K260884

FDA cleared the UNIDRIVE Select System from Karl Storz SE & CO. KG on Sep 1, 2026 under K260884, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 17, 2026. The decision came 168 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: K260581 (KARL STORZ Flexible Video Neuro-Endoscope), 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).

Questions & Answers

What did FDA clear under K260884?

K260884 is the FDA 510(k) for UNIDRIVE Select System, submitted by Karl Storz SE & CO. KG. FDA's decision date was Sep 1, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the UNIDRIVE Select System?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K260884.

How long did the K260884 review take?

FDA received the submission on Mar 17, 2026 and issued its decision on Sep 1, 2026, 168 days later.

← All decisions in September 2026