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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 / May 2026 / K260775

510(k) cleared

Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape

Teleflex Medical, LLC · May 6, 2026 · K260775

FDA cleared the Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape from Teleflex Medical, LLC on May 6, 2026 under K260775, a traditional 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 Mar 10, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Teleflex Medical, LLC has one other decision in the tracker over the last 12 months: K261988 (Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture).

Questions & Answers

What did FDA clear under K260775?

K260775 is the FDA 510(k) for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape, submitted by Teleflex Medical, LLC. FDA's decision date was May 6, 2026, under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Who makes the Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape?

Teleflex Medical, LLC, based in Morrisville, NC, is the applicant of record for K260775.

How long did the K260775 review take?

FDA received the submission on Mar 10, 2026 and issued its decision on May 6, 2026, 57 days later.

← All decisions in May 2026

Sources