FDA 510(k)

Tri-Staple 2.0 Reloads

Número K: K202864 · 2020-10-28

Data da decisão2020-10-28

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tri-Staple 2.0 Reloads is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K202864. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tri-Staple 2.0 Reloads?

Tri-Staple 2.0 Reloads is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Covidien. The 510(k) number is K202864.

When did Tri-Staple 2.0 Reloads receive FDA 510(k) clearance?

Tri-Staple 2.0 Reloads received FDA 510(k) clearance on 2020-10-28, under 510(k) number K202864.

Who is the listed applicant for Tri-Staple 2.0 Reloads?

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 Tri-Staple 2.0 Reloads?

The FDA product code for Tri-Staple 2.0 Reloads is GDW.

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)K231491TA™ Stapler and Loading Unit with DST Series™ Technology

Ver todos os 61 dispositivos →

Dispositivos Relacionados (Código: GDW)

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.