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 / October 2025 / K250767

510(k) cleared

Newclip Patient-matched instrumentation non sterile PSI

Newclip Technics · Oct 1, 2025 · K250767

FDA cleared the Newclip Patient-matched instrumentation non sterile PSI from Newclip Technics on Oct 1, 2025 under K250767, a traditional 510(k). The device falls under product code PBF, Orthopaedic Surgical Planning And Instrument Guides, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 13, 2025. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Newclip Technics has 4 other decisions in the tracker over the last 12 months: K261511 (Xpert Ankle), K261191 (Alians Elbow S), K261038 (Xpert PFP), K253906 (Xpert Hand).

Questions & Answers

What did FDA clear under K250767?

K250767 is the FDA 510(k) for Newclip Patient-matched instrumentation non sterile PSI, submitted by Newclip Technics. FDA's decision date was Oct 1, 2025, under product code PBF (Orthopaedic Surgical Planning And Instrument Guides).

Who makes the Newclip Patient-matched instrumentation non sterile PSI?

Newclip Technics, based in Haute Goulaine, is the applicant of record for K250767.

How long did the K250767 review take?

FDA received the submission on Mar 13, 2025 and issued its decision on Oct 1, 2025, 202 days later.

← All decisions in October 2025

Sources