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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 / September 2025 / K252647

510(k) cleared

Tapestry Biointegrative Implant

Embody, Inc. · Sep 19, 2025 · K252647

FDA cleared the Tapestry Biointegrative Implant from Embody, Inc. on Sep 19, 2025 under K252647, a special 510(k). The device falls under product code OWY, Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 21, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Embody, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252647?

K252647 is the FDA 510(k) for Tapestry Biointegrative Implant, submitted by Embody, Inc.. FDA's decision date was Sep 19, 2025, under product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon).

Who makes the Tapestry Biointegrative Implant?

Embody, Inc., based in Norfolk, VA, is the applicant of record for K252647.

How long did the K252647 review take?

FDA received the submission on Aug 21, 2025 and issued its decision on Sep 19, 2025, 29 days later.

← All decisions in September 2025