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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 / July 2026 / K261988

510(k) cleared

Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture

Teleflex Medical, LLC · Jul 9, 2026 · K261988

FDA cleared the Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture from Teleflex Medical, LLC on Jul 9, 2026 under K261988, a special 510(k). The device falls under product code NEW, Suture, Surgical, Absorbable, Polydioxanone, regulated at 21 CFR 878.4840 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 12, 2026. The decision came 27 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: K260775 (Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape).

Questions & Answers

What did FDA clear under K261988?

K261988 is the FDA 510(k) for Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture, submitted by Teleflex Medical, LLC. FDA's decision date was Jul 9, 2026, under product code NEW (Suture, Surgical, Absorbable, Polydioxanone).

Who makes the Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture?

Teleflex Medical, LLC, based in Morrisville, NC, is the applicant of record for K261988.

How long did the K261988 review take?

FDA received the submission on Jun 12, 2026 and issued its decision on Jul 9, 2026, 27 days later.

← All decisions in July 2026

Sources