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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 / December 2025 / P240035

PMA approved

ETHIZIA

ETHICON, Inc. · Dec 15, 2025 · P240035

FDA approved the ETHIZIA from ETHICON, Inc. on Dec 15, 2025 under P240035, an original premarket approval. The device falls under product code SGV, Agent, Absorbable Hemostatic, Collagen With Polymeric Additives, regulated at 21 CFR 878.4490 as a Class 3 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Oct 17, 2024. The decision came 424 days later.

ETHICON, Inc. has 6 other decisions in the tracker over the last 12 months: K253394 (Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture), K252047 (STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices), K253572 (STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device), K253852 (MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture).

Questions & Answers

What did FDA approve under P240035?

P240035 is the FDA PMA for ETHIZIA, submitted by ETHICON, Inc.. FDA's decision date was Dec 15, 2025, under product code SGV (Agent, Absorbable Hemostatic, Collagen With Polymeric Additives).

Who makes the ETHIZIA?

ETHICON, Inc., based in Raritan, NJ, is the applicant of record for P240035.

How long did the P240035 review take?

FDA received the submission on Oct 17, 2024 and issued its decision on Dec 15, 2025, 424 days later.

← All decisions in December 2025