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The Tracker / March 2026 / K260271

510(k) cleared

Strauss Surgical cystoscope, hysteroscope and accessories Instruments

American Medical Endoscopy, Inc. · Mar 27, 2026 · K260271

FDA cleared the Strauss Surgical cystoscope, hysteroscope and accessories Instruments from American Medical Endoscopy, Inc. on Mar 27, 2026 under K260271, a traditional 510(k). The device falls under product code FAJ, Cystoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 28, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

American Medical Endoscopy, Inc. has one other decision in the tracker over the last 12 months: K253020 (Strauss Surgical Resection Instruments).

Questions & Answers

What did FDA clear under K260271?

K260271 is the FDA 510(k) for Strauss Surgical cystoscope, hysteroscope and accessories Instruments, submitted by American Medical Endoscopy, Inc.. FDA's decision date was Mar 27, 2026, under product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Who makes the Strauss Surgical cystoscope, hysteroscope and accessories Instruments?

American Medical Endoscopy, Inc., based in Doral, FL, is the applicant of record for K260271.

How long did the K260271 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Mar 27, 2026, 58 days later.

← All decisions in March 2026

Sources