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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 / K260403

510(k) cleared

7D Surgical System (10-0001)

7D Surgical ULC · Oct 19, 2026 · K260403

FDA cleared the 7D Surgical System (10-0001) from 7D Surgical ULC on Oct 19, 2026 under K260403, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 6, 2026. The decision came 255 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 7D Surgical ULC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260403?

K260403 is the FDA 510(k) for 7D Surgical System (10-0001), submitted by 7D Surgical ULC. FDA's decision date was Oct 19, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the 7D Surgical System (10-0001)?

7D Surgical ULC, based in Toronto, is the applicant of record for K260403.

How long did the K260403 review take?

FDA received the submission on Feb 6, 2026 and issued its decision on Oct 19, 2026, 255 days later.

← All decisions in October 2026