Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes

Número K: K221743 · 2023-09-07

RequerenteJiangsu Bonss Medical Technology Co., Ltd.
Data da decisão2023-09-07
Código do produtoGEI
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Bonss Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K221743. 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 Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Jiangsu Bonss Medical Technology Co., Ltd.. The 510(k) number is K221743.

When did Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes receive FDA 510(k) clearance?

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes received FDA 510(k) clearance on 2023-09-07, under 510(k) number K221743.

Who is the listed applicant for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

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

What is the FDA product code for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes?

The FDA product code for Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: GEI)

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.

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261959Neptune® 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 InstrumentsK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet 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.

↑