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 / K253024

510(k) cleared

ProZip Knotless Implant

Riverpoint Medical · Oct 16, 2025 · K253024

FDA cleared the ProZip Knotless Implant from Riverpoint Medical on Oct 16, 2025 under K253024, a special 510(k). The device falls under product code GAT, Suture, Nonabsorbable, Synthetic, Polyethylene, regulated at 21 CFR 878.5000 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 19, 2025. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Riverpoint Medical has 2 other decisions in the tracker over the last 12 months: K253693 (Strut Suture; No-Tie Button), K253695 (LigaMend).

Questions & Answers

What did FDA clear under K253024?

K253024 is the FDA 510(k) for ProZip Knotless Implant, submitted by Riverpoint Medical. FDA's decision date was Oct 16, 2025, under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Who makes the ProZip Knotless Implant?

Riverpoint Medical, based in Portland, OR, is the applicant of record for K253024.

How long did the K253024 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Oct 16, 2025, 27 days later.

← All decisions in October 2025

Sources