FDA 510(k)

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments

Número K: K163615 · 2017-05-04

Data da decisão2017-05-04

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2017-05-04 under 510(k) number K163615. 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 Snowden-Pencer MicroLap 3mm Laparoscopic Instruments?

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K163615.

When did Snowden-Pencer MicroLap 3mm Laparoscopic Instruments receive FDA 510(k) clearance?

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments received FDA 510(k) clearance on 2017-05-04, under 510(k) number K163615.

Who is the listed applicant for Snowden-Pencer MicroLap 3mm Laparoscopic Instruments?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Snowden-Pencer MicroLap 3mm Laparoscopic Instruments?

The FDA product code for Snowden-Pencer MicroLap 3mm Laparoscopic Instruments 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 Carefusion 2200, Inc. como candidato(a)

K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 K162432Multi-Link X2 ECG Cable and Lead Wire System K160764Câmara de Humidificação Autofill AirLife K153554Genesis Low Temperature Reusable Rigid Container System K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments

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.