FDA 510(k)

Implanter incl. Accessories

Número K: K211358 · 2022-11-21

RequerenteGuilin Woodpecker Medical Instrument Co., Ltd.

Data da decisão2022-11-21

Código do produtoEBW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Implanter incl. Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K211358. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Implanter incl. Accessories?

Implanter incl. Accessories is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K211358.

When did Implanter incl. Accessories receive FDA 510(k) clearance?

Implanter incl. Accessories received FDA 510(k) clearance on 2022-11-21, under 510(k) number K211358.

Who is the listed applicant for Implanter incl. Accessories?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implanter incl. Accessories?

The FDA product code for Implanter incl. Accessories is EBW.

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 Guilin Woodpecker Medical Instrument Co., Ltd. como candidato(a)

K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )K222569Dispositivo de Raio X Dental Ai Ray K221548Dental Air Polishing Handpiece K210367D-Laser Blue, D-Laser 16 K203706Dental Electric Motor K211531Cordless Prophy System, Model: i-Polish

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: EBW)

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental Division K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

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.