WHERE ARE YOU?

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

THE TAPE

FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K260581

510(k) cleared

KARL STORZ Flexible Video Neuro-Endoscope

Karl Storz SE & CO. KG · Oct 14, 2026 · K260581

FDA cleared the KARL STORZ Flexible Video Neuro-Endoscope from Karl Storz SE & CO. KG on Oct 14, 2026 under K260581, a traditional 510(k). The device falls under product code GWG, Endoscope, Neurological, regulated at 21 CFR 882.1480 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 20, 2026. The decision came 236 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 K260581?

K260581 is the FDA 510(k) for KARL STORZ Flexible Video Neuro-Endoscope, submitted by Karl Storz SE & CO. KG. FDA's decision date was Oct 14, 2026, under product code GWG (Endoscope, Neurological).

Who makes the KARL STORZ Flexible Video Neuro-Endoscope?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K260581.

How long did the K260581 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on Oct 14, 2026, 236 days later.

← All decisions in October 2026