免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Omnitech HF 切割电极，Omnitech HF 蒸发电极

K号: K151976 · 2016-06-27

申请人Omnitech Systems, Inc.
决定日期2016-06-27
产品代码FAS
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Omnitech Systems, Inc.. It received FDA 510(k) clearance on 2016-06-27 under 510(k) number K151976. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is a medical device that received FDA 510(k) clearance on 2016-06-27. The listed applicant is Omnitech Systems, Inc.. The 510(k) number is K151976.

When did Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode receive FDA 510(k) clearance?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode received FDA 510(k) clearance on 2016-06-27, under 510(k) number K151976.

Who is the listed applicant for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

The FDA 510(k) record lists Omnitech Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

The FDA product code for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is FAS.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：FAS）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251403Dornier 双极电极 BIP12CLM 双极 12° 中度切割环 24 Fr 电极-无菌，一次性使用 BIP12CLL 双极 12° 大度切割环 24 Fr 电极-无菌，一次性使用 BIP30CLM 双极 30° 中度切割环 24 Fr 电极-无菌，一次性使用 BIP30CLL 双极 30° 大度切割环 24 Fr 电极-无菌，一次性使用 BIPMBLA 双极中度膀胱环 24 Fr 电极-无菌，一次性使用 BIPNEEL 双极针 24 Fr 电极-无菌，一次性使用 BIPDDSC 双极盘 )Dornier Medtech America Inc (Dmta)K250522Multi4系统Multi4 Medical ABK240504PLASMA EDGE 系统Lamidey Noury MedicalK213135Plasma Edge切除和汽化电极，Plasma Edge工作元件，适配器Plasma EdgeChirurgie InnovationK210651带 HF 电缆的 Resection 电极Olympus Winter & Ibe GmbHK210394电外科附件Dornier Medtech America, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑