FDA 510(k)

SMARTRELEASE Endoscopic Soft Tissue Release System

Número K: K181819 · 2018-11-06

RequerenteMicroaire Surgical Instruments, LLC

Data da decisão2018-11-06

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SMARTRELEASE Endoscopic Soft Tissue Release System is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K181819. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SMARTRELEASE Endoscopic Soft Tissue Release System?

SMARTRELEASE Endoscopic Soft Tissue Release System is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is Microaire Surgical Instruments, LLC. The 510(k) number is K181819.

When did SMARTRELEASE Endoscopic Soft Tissue Release System receive FDA 510(k) clearance?

SMARTRELEASE Endoscopic Soft Tissue Release System received FDA 510(k) clearance on 2018-11-06, under 510(k) number K181819.

Who is the listed applicant for SMARTRELEASE Endoscopic Soft Tissue Release System?

The FDA 510(k) record lists Microaire Surgical Instruments, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTRELEASE Endoscopic Soft Tissue Release System?

The FDA product code for SMARTRELEASE Endoscopic Soft Tissue Release System is HRX.

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 Microaire Surgical Instruments, LLC como candidato(a)

K243589PAL Sterilization Case K244026PAL 7020 Console K242804PAL Aspiration System K220318PAL Infiltration System K212024PAL System K171286PAL Multi-Use Cannulas and PAL Manual Wand

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: HRX)

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC K253523Freedom DS™ Decompression SystemSpinal Simplicity K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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.