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THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K262007

510(k) cleared

PRIMED AAMI Level 3 Open Back Gowns

PRIMED Medical Products, Inc. · Sep 11, 2026 · K262007

FDA cleared the PRIMED AAMI Level 3 Open Back Gowns from PRIMED Medical Products, Inc. on Sep 11, 2026 under K262007, a traditional 510(k). The device falls under product code QPC, Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 15, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

PRIMED Medical Products, Inc. has 2 other decisions in the tracker over the last 12 months: K261811 (PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)), K252964 (PRIMED Surgical and Procedure Masks).

Questions & Answers

What did FDA clear under K262007?

K262007 is the FDA 510(k) for PRIMED AAMI Level 3 Open Back Gowns, submitted by PRIMED Medical Products, Inc.. FDA's decision date was Sep 11, 2026, under product code QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection).

Who makes the PRIMED AAMI Level 3 Open Back Gowns?

PRIMED Medical Products, Inc., based in Edmonton, is the applicant of record for K262007.

How long did the K262007 review take?

FDA received the submission on Jun 15, 2026 and issued its decision on Sep 11, 2026, 88 days later.

← All decisions in September 2026

Sources