OpClear System

510(k) Number

K171637 ↗

FDA product code

OCX

Device class

Class II

Regulation

21 CFR Part 876.1500

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code OCX (Endoscopic Irrigation/Suction System).

• Lavaging Catheters by American Endoscopy, Inc.
• Aspiration Catheter 2189 by HOBBS MEDICAL, INC.
• ENDOGATOR 100241 by MEDIVATORS INC.
• ENDOGATOR 200230 by MEDIVATORS INC.
• Irrigation System by United States Endoscopy Group, Inc.
• ArgoCap 200.52 by Ovesco Endoscopy AG
• Syringe Assist Irrigation System by C. R. Bard, Inc.
• ClearCap Distal Attachment by Finemedix Co., Ltd.
• Air/Water Bottle Tubing, CO2 Source Tubing by ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
• Andorate Auxiliary Water Connector by Smartdata Suzhou Co., Ltd.

• CS-05-30-290 OpClear Disposable

  Class II

  FDA 510(k) K221824 Active Cleared 19 Aug 2022 GUDID on market

• CS-05-00-300 OpClear Disposable

  Class II

  CE/MDR FDA 510(k) K221824 Active Cleared 19 Aug 2022 +1authorizations

• CS-05-00-290 OpClear Disposable

  Class II

  FDA 510(k) K221824 Active Cleared 19 Aug 2022 GUDID on market

• CS-05-30-300 OpClear Disposable

  Class II

  CE/MDR FDA 510(k) K221824 Active Cleared 19 Aug 2022 +1authorizations

See all devices from Cipher Surgical, Ltd. →