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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 / K262184

510(k) cleared

GANNET®

BAAT Medical Products B.V. · Oct 22, 2026 · K262184

FDA cleared the GANNET® from BAAT Medical Products B.V. on Oct 22, 2026 under K262184, a traditional 510(k). The device falls under product code JDO, Device, Fixation, Proximal Femoral, Implant, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 29, 2026. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

BAAT Medical Products B.V. has 2 other decisions in the tracker over the last 12 months: K254176 (SINEFIX), K251961 (SDS Growing Rod).

Questions & Answers

What did FDA clear under K262184?

K262184 is the FDA 510(k) for GANNET®, submitted by BAAT Medical Products B.V.. FDA's decision date was Oct 22, 2026, under product code JDO (Device, Fixation, Proximal Femoral, Implant).

Who makes the GANNET®?

BAAT Medical Products B.V., based in Hengelo, is the applicant of record for K262184.

How long did the K262184 review take?

FDA received the submission on Jun 29, 2026 and issued its decision on Oct 22, 2026, 115 days later.

← All decisions in October 2026

Sources