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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 / June 2026 / K260726

510(k) cleared

Straumann® ProClean Cassette (041.800 ; 041.801)

Institut Straumann AG · Jun 3, 2026 · K260726

FDA cleared the Straumann® ProClean Cassette (041.800 ; 041.801) from Institut Straumann AG on Jun 3, 2026 under K260726, a traditional 510(k). The device falls under product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 5, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Institut Straumann AG has 3 other decisions in the tracker over the last 12 months: K260460 (Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue), K252168 (Straumann® BLC Implants - Indication Widening), K253315 (Straumann Variobase Abutments XC for Bridge/Bar).

Questions & Answers

What did FDA clear under K260726?

K260726 is the FDA 510(k) for Straumann® ProClean Cassette (041.800 ; 041.801), submitted by Institut Straumann AG. FDA's decision date was Jun 3, 2026, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the Straumann® ProClean Cassette (041.800 ; 041.801)?

Institut Straumann AG, based in Basel, is the applicant of record for K260726.

How long did the K260726 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on Jun 3, 2026, 90 days later.

← All decisions in June 2026

Sources