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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 / October 2025 / K242100

510(k) cleared

SurgiAid Collagen Wound Dressing (HA)

Maxigen Biotech, Inc. · Oct 16, 2025 · K242100

FDA cleared the SurgiAid Collagen Wound Dressing (HA) from Maxigen Biotech, Inc. on Oct 16, 2025 under K242100, a traditional 510(k). The device falls under product code KGN, Wound Dressing With Animal-Derived Material(S) as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jul 18, 2024. The decision came 455 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K242100?

K242100 is the FDA 510(k) for SurgiAid Collagen Wound Dressing (HA), submitted by Maxigen Biotech, Inc.. FDA's decision date was Oct 16, 2025, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the SurgiAid Collagen Wound Dressing (HA)?

Maxigen Biotech, Inc., based in Taoyuan, is the applicant of record for K242100.

How long did the K242100 review take?

FDA received the submission on Jul 18, 2024 and issued its decision on Oct 16, 2025, 455 days later.

← All decisions in October 2025