FDA 510(k)

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider

Número K: K161804 · 2016-09-16

Data da decisão2016-09-16

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K161804. 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 LigaSure Retractable L-Hook Laparoscopic Sealer/Divider?

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Covidien. The 510(k) number is K161804.

When did LigaSure Retractable L-Hook Laparoscopic Sealer/Divider receive FDA 510(k) clearance?

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider received FDA 510(k) clearance on 2016-09-16, under 510(k) number K161804.

Who is the listed applicant for LigaSure Retractable L-Hook Laparoscopic Sealer/Divider?

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

What is the FDA product code for LigaSure Retractable L-Hook Laparoscopic Sealer/Divider?

The FDA product code for LigaSure Retractable L-Hook Laparoscopic Sealer/Divider 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 Covidien como candidato(a)

K241486Sofsilk™ Coated Braided Silk Suture K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)K231934GIA™ Stapler with Tri-Staple™ Technology K231240MaxTack™ Motorized Fixation Device K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

Ver todos os 61 dispositivos →

Dispositivos Relacionados (Código: 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.

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.