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The Tracker / August 2026 / K260209

510(k) cleared

ENDOFLATOR+; Smart Smoke Evacuation

Karl Storz SE & CO. KG · Aug 19, 2026 · K260209

FDA cleared the ENDOFLATOR+; Smart Smoke Evacuation from Karl Storz SE & CO. KG on Aug 19, 2026 under K260209, a traditional 510(k). The device falls under product code HIF, Insufflator, Laparoscopic, regulated at 21 CFR 884.1730 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jan 23, 2026. The decision came 208 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: K254103 (HOPKINS Telescopes for Arthroscopy), K261706 (Endomat Select (UP220)), K252800 (KARL STORZ Endoscopic Accessories for Urology), K252624 (KARL STORZ Laryngoscopes and Accessories).

Questions & Answers

What did FDA clear under K260209?

K260209 is the FDA 510(k) for ENDOFLATOR+; Smart Smoke Evacuation, submitted by Karl Storz SE & CO. KG. FDA's decision date was Aug 19, 2026, under product code HIF (Insufflator, Laparoscopic).

Who makes the ENDOFLATOR+; Smart Smoke Evacuation?

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K260209.

How long did the K260209 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Aug 19, 2026, 208 days later.

← All decisions in August 2026