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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 a medical device manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-06 under approval 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. It is manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The 510(k) number is K201641.

When was Disposable Laparoscope Trocar approved by the FDA?

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

What company makes Disposable Laparoscope Trocar?

Disposable Laparoscope Trocar is manufactured by Beijing Biosis Healing Biolog Ical Technology Co., Ltd..

What is the FDA product code for Disposable Laparoscope Trocar?

The FDA product code for Disposable Laparoscope Trocar is GCJ.

Other Devices by Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K202029Medical Surgical Mask K201243Disposable Specimen Retrieval Bag K203622Medical Gloves K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads K202844Medical Surgical Gowns K231513Oral Matrix

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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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