WHERE ARE YOU?

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

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K253020

510(k) cleared

Strauss Surgical Resection Instruments

American Medical Endoscopy, Inc. · Jun 4, 2026 · K253020

FDA cleared the Strauss Surgical Resection Instruments from American Medical Endoscopy, Inc. on Jun 4, 2026 under K253020, a traditional 510(k). The device falls under product code HIH, Hysteroscope (And Accessories), regulated at 21 CFR 884.1690 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Sep 19, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

American Medical Endoscopy, Inc. has one other decision in the tracker over the last 12 months: K260271 (Strauss Surgical cystoscope, hysteroscope and accessories Instruments).

Questions & Answers

What did FDA clear under K253020?

K253020 is the FDA 510(k) for Strauss Surgical Resection Instruments, submitted by American Medical Endoscopy, Inc.. FDA's decision date was Jun 4, 2026, under product code HIH (Hysteroscope (And Accessories)).

Who makes the Strauss Surgical Resection Instruments?

American Medical Endoscopy, Inc., based in Doral, FL, is the applicant of record for K253020.

How long did the K253020 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Jun 4, 2026, 258 days later.

← All decisions in June 2026

Sources