FDA 510(k)

TauTona Pneumoperitoneum Assist Device (TPAD)

N.º K: K233020 · 2024-01-12

SolicitanteTautona Group Research & Development, Co., LLC

Fecha de decisión2024-01-12

Código de productoHIF

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

TauTona Pneumoperitoneum Assist Device (TPAD) is the device name listed in this FDA 510(k) record. The listed applicant is Tautona Group Research & Development, Co., LLC. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233020. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TauTona Pneumoperitoneum Assist Device (TPAD)?

TauTona Pneumoperitoneum Assist Device (TPAD) is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Tautona Group Research & Development, Co., LLC. The 510(k) number is K233020.

When did TauTona Pneumoperitoneum Assist Device (TPAD) receive FDA 510(k) clearance?

TauTona Pneumoperitoneum Assist Device (TPAD) received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233020.

Who is the listed applicant for TauTona Pneumoperitoneum Assist Device (TPAD)?

The FDA 510(k) record lists Tautona Group Research & Development, Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TauTona Pneumoperitoneum Assist Device (TPAD)?

The FDA product code for TauTona Pneumoperitoneum Assist Device (TPAD) is HIF.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Dispositivos relacionados (Código: HIF)

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KG K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.