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FDA 510(k)

Disposable Laparoscope Trocar

K-Number: K201641 · 2020-08-06

ApplicantBeijing Biosis Healing Biolog Ical Technology Co., Ltd.
Decision Date2020-08-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Official Source

View on FDA Database →

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

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