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FDA 510(k)

Disposable Endoscopic Bipolar

K-Number: K231615 · 2023-12-05

ApplicantJiangsu Hope Biomedical Science & Technology Co., Ltd.
Decision Date2023-12-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopic Bipolar is a medical device manufactured by Jiangsu Hope Biomedical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-05 under approval number K231615. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Endoscopic Bipolar?

Disposable Endoscopic Bipolar is a medical device that received FDA 510(k) clearance on 2023-12-05. It is manufactured by Jiangsu Hope Biomedical Science & Technology Co., Ltd.. The 510(k) number is K231615.

When was Disposable Endoscopic Bipolar approved by the FDA?

Disposable Endoscopic Bipolar received FDA 510(k) clearance on 2023-12-05, under approval number K231615.

What company makes Disposable Endoscopic Bipolar?

Disposable Endoscopic Bipolar is manufactured by Jiangsu Hope Biomedical Science & Technology Co., Ltd..

What is the FDA product code for Disposable Endoscopic Bipolar?

The FDA product code for Disposable Endoscopic Bipolar is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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