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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 / March 2026 / K254170

510(k) cleared

Percutaneous Endoscopic Gastrostomy (PEG) Kit

Degania Silicone , Ltd. · Mar 20, 2026 · K254170

FDA cleared the Percutaneous Endoscopic Gastrostomy (PEG) Kit from Degania Silicone , Ltd. on Mar 20, 2026 under K254170, a traditional 510(k). The device falls under product code PIF, Gastrointestinal Tubes With Enteral Specific Connectors, regulated at 21 CFR 876.5980 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 23, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Degania Silicone , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254170?

K254170 is the FDA 510(k) for Percutaneous Endoscopic Gastrostomy (PEG) Kit, submitted by Degania Silicone , Ltd.. FDA's decision date was Mar 20, 2026, under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors).

Who makes the Percutaneous Endoscopic Gastrostomy (PEG) Kit?

Degania Silicone , Ltd., based in Degania Bet, is the applicant of record for K254170.

How long did the K254170 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Mar 20, 2026, 87 days later.

← All decisions in March 2026