Cleared Traditional

Disposable Specimen Retrieval Bag

K201243 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · General & Plastic Surgery

Jul 2020

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K201243 is an FDA 510(k) clearance for the Disposable Specimen Retrieval Bag, 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 July 10, 2020, 63 days after receiving the submission on May 8, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K201243 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2020
Decision Date	July 10, 2020
Days to Decision	63 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).