Disposable Specimen Retrieval Bag

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

510(k) K201243

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

510(k) K201243↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK201243	Date10 Jul 2020Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K201243
FDA Product Code: GCJ

Device Class: Class II
Regulation: 21 CFR Part 876.1500
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

Other devices from Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

Vidasis®

Class III
Medical Gloves

Class I
Disposable Laparoscope Trocar

Class II
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

Class II
Medical Surgical Gowns

Class II
Oral Matrix

Class II

See all devices from Beijing Biosis Healing Biolog Ical Technology Co., Ltd. →