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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 / January 2026 / K253550

510(k) cleared

Self-Forming Magnet (Flexagon Plus OTOLoc)

GI Windows, Inc. · Jan 9, 2026 · K253550

FDA cleared the Self-Forming Magnet (Flexagon Plus OTOLoc) from GI Windows, Inc. on Jan 9, 2026 under K253550, a traditional 510(k). The device falls under product code SAH, Magnetic Compression Anastomosis System, regulated at 21 CFR 878.4816 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 14, 2025. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for GI Windows, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253550?

K253550 is the FDA 510(k) for Self-Forming Magnet (Flexagon Plus OTOLoc), submitted by GI Windows, Inc.. FDA's decision date was Jan 9, 2026, under product code SAH (Magnetic Compression Anastomosis System).

Who makes the Self-Forming Magnet (Flexagon Plus OTOLoc)?

GI Windows, Inc., based in Westwood, MA, is the applicant of record for K253550.

How long did the K253550 review take?

FDA received the submission on Nov 14, 2025 and issued its decision on Jan 9, 2026, 56 days later.

← All decisions in January 2026