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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262917

510(k) cleared

Reprocessed BRK Transseptal Needle

Innovative Health, LLC · Oct 19, 2026 · K262917

FDA cleared the Reprocessed BRK Transseptal Needle from Innovative Health, LLC on Oct 19, 2026 under K262917, a traditional 510(k). The device falls under product code NMK, Trocar, Reprocessed, regulated at 21 CFR 870.1390 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 20, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Innovative Health, LLC has one other decision in the tracker over the last 12 months: K250305 (Reprocessed Agilis NxT Steerable Introducer).

Questions & Answers

What did FDA clear under K262917?

K262917 is the FDA 510(k) for Reprocessed BRK Transseptal Needle, submitted by Innovative Health, LLC. FDA's decision date was Oct 19, 2026, under product code NMK (Trocar, Reprocessed).

Who makes the Reprocessed BRK Transseptal Needle?

Innovative Health, LLC, based in Scottsdale, AZ, is the applicant of record for K262917.

How long did the K262917 review take?

FDA received the submission on Aug 20, 2026 and issued its decision on Oct 19, 2026, 60 days later.

← All decisions in October 2026

Sources