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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K260756

510(k) cleared

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

Sentinel Medical Technologies, · Sep 4, 2026 · K260756

FDA cleared the TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) from Sentinel Medical Technologies, on Sep 4, 2026 under K260756, a traditional 510(k). The device falls under product code EZL, Catheter, Retention Type, Balloon, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 9, 2026. The decision came 179 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 Sentinel Medical Technologies, in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260756?

K260756 is the FDA 510(k) for TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221), submitted by Sentinel Medical Technologies,. FDA's decision date was Sep 4, 2026, under product code EZL (Catheter, Retention Type, Balloon).

Who makes the TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)?

Sentinel Medical Technologies,, based in Jacksonville, FL, is the applicant of record for K260756.

How long did the K260756 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Sep 4, 2026, 179 days later.

← All decisions in September 2026