FDA 510(k)

一次性腹腔镜穿刺器

K 號：K201641 · 2020-08-06

申請人Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

決定日期2020-08-06

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Disposable Laparoscope Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201641. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Laparoscope Trocar?

Disposable Laparoscope Trocar is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The 510(k) number is K201641.

When did Disposable Laparoscope Trocar receive FDA 510(k) clearance?

Disposable Laparoscope Trocar received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201641.

Who is the listed applicant for Disposable Laparoscope Trocar?

The FDA 510(k) record lists Beijing Biosis Healing Biolog Ical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Laparoscope Trocar?

The FDA product code for Disposable Laparoscope Trocar is GCJ.