FDA 510(k)

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

Número K: K213831 · 2022-01-04

Data da decisão2022-01-04

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2022-01-04 under 510(k) number K213831. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle is a medical device that received FDA 510(k) clearance on 2022-01-04. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K213831.

When did Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle receive FDA 510(k) clearance?

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle received FDA 510(k) clearance on 2022-01-04, under 510(k) number K213831.

Who is the listed applicant for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle?

The FDA product code for Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle is GEI.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Gyrus Acmi, Inc. como candidato(a)

K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)K231327POWERSEAL Sealer and Divider K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories K212650Celeris, Disposable Sinus Debrider K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

Ver todos os 15 dispositivos →

Dispositivos Relacionados (Código: 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.