FDA 510(k)

Prana System

Номер K: K253405 · 2026-04-01

Дата решения2026-04-01

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Prana System is the device name listed in this FDA 510(k) record. The listed applicant is Prana Surgical. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K253405. 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 Prana System?

Prana System is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Prana Surgical. The 510(k) number is K253405.

When did Prana System receive FDA 510(k) clearance?

Prana System received FDA 510(k) clearance on 2026-04-01, under 510(k) number K253405.

Who is the listed applicant for Prana System?

The FDA 510(k) record lists Prana Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prana System?

The FDA product code for Prana System 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)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC 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 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

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