WHERE ARE YOU?

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

THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K254103

510(k) cleared

HOPKINS Telescopes for Arthroscopy

Karl Storz SE & CO. KG · Aug 26, 2026 · K254103

FDA cleared the HOPKINS Telescopes for Arthroscopy from Karl Storz SE & CO. KG on Aug 26, 2026 under K254103, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 19, 2025. The decision came 250 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: K260209 (ENDOFLATOR+; Smart Smoke Evacuation), K261706 (Endomat Select (UP220)), K252800 (KARL STORZ Endoscopic Accessories for Urology), K252624 (KARL STORZ Laryngoscopes and Accessories).

Questions & Answers

What did FDA clear under K254103?

K254103 is the FDA 510(k) for HOPKINS Telescopes for Arthroscopy, submitted by Karl Storz SE & CO. KG. FDA's decision date was Aug 26, 2026, under product code HRX (Arthroscope).

Who makes the HOPKINS Telescopes for Arthroscopy?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K254103.

How long did the K254103 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Aug 26, 2026, 250 days later.

← All decisions in August 2026