Cleared Traditional

K201641 - Disposable Laparoscope Trocar
(FDA 510(k) Clearance)

K201641 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · General & Plastic Surgery

Aug 2020

Decision

51d

Days

Class 2

Risk

K201641 is an FDA 510(k) clearance for the Disposable Laparoscope Trocar, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on August 6, 2020, 51 days after receiving the submission on June 16, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K201641 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2020
Decision Date	August 06, 2020
Days to Decision	51 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).