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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 / K261684

510(k) cleared

FreezeSpray TA

Cryosurgery, Inc. · Sep 5, 2026 · K261684

FDA cleared the FreezeSpray TA from Cryosurgery, Inc. on Sep 5, 2026 under K261684, a traditional 510(k). The device falls under product code MLY, Vapocoolant Device as a Class U device. The review panel was Unknown.

FDA logged the submission as received on May 21, 2026. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cryosurgery, Inc. has 2 other decisions in the tracker over the last 12 months: K253000 (CryoFreeze Wart and Skin Tag Remover), K252903 (Verruca-Freeze H Plus).

Questions & Answers

What did FDA clear under K261684?

K261684 is the FDA 510(k) for FreezeSpray TA, submitted by Cryosurgery, Inc.. FDA's decision date was Sep 5, 2026, under product code MLY (Vapocoolant Device).

Who makes the FreezeSpray TA?

Cryosurgery, Inc., based in Nashville, TN, is the applicant of record for K261684.

How long did the K261684 review take?

FDA received the submission on May 21, 2026 and issued its decision on Sep 5, 2026, 107 days later.

← All decisions in September 2026

Sources