WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K260246

510(k) cleared

SEISMIQ Intravascular Lithotripsy System

Bolt Medical, Inc. · Aug 24, 2026 · K260246

FDA cleared the SEISMIQ Intravascular Lithotripsy System from Bolt Medical, Inc. on Aug 24, 2026 under K260246, a traditional 510(k). The device falls under product code PPN, Percutaneous Catheter, Ultrasound, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 27, 2026. The decision came 209 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 Bolt Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260246?

K260246 is the FDA 510(k) for SEISMIQ Intravascular Lithotripsy System, submitted by Bolt Medical, Inc.. FDA's decision date was Aug 24, 2026, under product code PPN (Percutaneous Catheter, Ultrasound).

Who makes the SEISMIQ Intravascular Lithotripsy System?

Bolt Medical, Inc., based in Carlsbad, CA, is the applicant of record for K260246.

How long did the K260246 review take?

FDA received the submission on Jan 27, 2026 and issued its decision on Aug 24, 2026, 209 days later.

← All decisions in August 2026