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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 / K261004

510(k) cleared

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)

Integra Lifesciences Production Corporation · Jun 23, 2026 · K261004

FDA cleared the Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) from Integra Lifesciences Production Corporation on Jun 23, 2026 under K261004, a traditional 510(k). The device falls under product code JXG, Shunt, Central Nervous System And Components, regulated at 21 CFR 882.5550 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 26, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Integra Lifesciences Production Corporation has one other decision in the tracker over the last 12 months: K251162 (CUSA® Clarity Ultrasonic Surgical Aspirator System).

Questions & Answers

What did FDA clear under K261004?

K261004 is the FDA 510(k) for Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684), submitted by Integra Lifesciences Production Corporation. FDA's decision date was Jun 23, 2026, under product code JXG (Shunt, Central Nervous System And Components).

Who makes the Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)?

Integra Lifesciences Production Corporation, based in Mansfield, MA, is the applicant of record for K261004.

How long did the K261004 review take?

FDA received the submission on Mar 26, 2026 and issued its decision on Jun 23, 2026, 89 days later.

← All decisions in June 2026

Sources