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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 / August 2026 / K260120

510(k) cleared

NaturaJel Oral Wound Care Kit

HCS Innovation, LLC · Aug 5, 2026 · K260120

FDA cleared the NaturaJel Oral Wound Care Kit from HCS Innovation, LLC on Aug 5, 2026 under K260120, a traditional 510(k). The device falls under product code OLR, Oral Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jan 15, 2026. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for HCS Innovation, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260120?

K260120 is the FDA 510(k) for NaturaJel Oral Wound Care Kit, submitted by HCS Innovation, LLC. FDA's decision date was Aug 5, 2026, under product code OLR (Oral Wound Dressing).

Who makes the NaturaJel Oral Wound Care Kit?

HCS Innovation, LLC, based in Union Grove, AL, is the applicant of record for K260120.

How long did the K260120 review take?

FDA received the submission on Jan 15, 2026 and issued its decision on Aug 5, 2026, 202 days later.

← All decisions in August 2026