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 / June 2026 / K260859

510(k) cleared

Rosetta SM, Rosetta SP

Hass Corp. · Jun 11, 2026 · K260859

FDA cleared the Rosetta SM, Rosetta SP from Hass Corp. on Jun 11, 2026 under K260859, a traditional 510(k). The device falls under product code EIH, Powder, Porcelain, regulated at 21 CFR 872.6660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 16, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hass Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260859?

K260859 is the FDA 510(k) for Rosetta SM, Rosetta SP, submitted by Hass Corp.. FDA's decision date was Jun 11, 2026, under product code EIH (Powder, Porcelain).

Who makes the Rosetta SM, Rosetta SP?

Hass Corp., based in Gangneung-Si, is the applicant of record for K260859.

How long did the K260859 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on Jun 11, 2026, 87 days later.

← All decisions in June 2026