FDA 510(k)

Cautery Protective Actuation System (CPAS)

Номер K: K232407 · 2023-10-06

ЗаявительSafer Surgeries Medical Devices, LLC

Дата решения2023-10-06

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Cautery Protective Actuation System (CPAS) is the device name listed in this FDA 510(k) record. The listed applicant is Safer Surgeries Medical Devices, LLC. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232407. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Cautery Protective Actuation System (CPAS)?

Cautery Protective Actuation System (CPAS) is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Safer Surgeries Medical Devices, LLC. The 510(k) number is K232407.

When did Cautery Protective Actuation System (CPAS) receive FDA 510(k) clearance?

Cautery Protective Actuation System (CPAS) received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232407.

Who is the listed applicant for Cautery Protective Actuation System (CPAS)?

The FDA 510(k) record lists Safer Surgeries Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cautery Protective Actuation System (CPAS)?

The FDA product code for Cautery Protective Actuation System (CPAS) is GEI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.