FDA 510(k)

Sutter Swyng 不粘雙極镊子，一次性使用

K 號：K193587 · 2020-02-10

決定日期2020-02-10

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Sutter Swyng non-stick bipolar forceps, single-use is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2020-02-10 under 510(k) number K193587. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sutter Swyng non-stick bipolar forceps, single-use?

Sutter Swyng non-stick bipolar forceps, single-use is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K193587.

When did Sutter Swyng non-stick bipolar forceps, single-use receive FDA 510(k) clearance?

Sutter Swyng non-stick bipolar forceps, single-use received FDA 510(k) clearance on 2020-02-10, under 510(k) number K193587.

Who is the listed applicant for Sutter Swyng non-stick bipolar forceps, single-use?

The FDA 510(k) record lists Sutter Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sutter Swyng non-stick bipolar forceps, single-use?

The FDA product code for Sutter Swyng non-stick bipolar forceps, single-use is GEI.

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