Product code OCX
- Device name
- Endoscopic Irrigation/Suction System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation | 2025-09-26 |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | 2025-09-25 |
| K242586 | ArgoCap (200.52) | Ovesco Endoscopy AG | 2025-05-22 |
| K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | 2025-03-20 |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | Olympus Medical Systems Corporation | 2024-10-07 |
| K241874 | Aspiration Catheter (2189) | Hobbs Medical, Inc. | 2024-09-24 |
| K242134 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2024-08-20 |
| K233442 | troCarWash™ System | Biotex, Inc. | 2024-05-21 |
| K230773 | Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-11-21 |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 |
| K231418 | ENDOGATOR™ Hybrid Irrigation Tubing | Medivators | 2023-08-14 |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | Ga Health Company Limited | 2023-08-01 |
| K230932 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023-07-07 |
| K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | Saneso, Inc. | 2023-02-27 |
| K222695 | troCarWash™ System | Biotex, Inc. | 2023-02-17 |
| K223171 | AquaPulse® Irrigation Tubing | Ga Health Company Limited | 2022-11-10 |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | Diversatek Healthcare | 2022-11-08 |
| K221310 | Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing | Changzhou Endoclean Medical Device Co., Ltd. | 2022-10-07 |
| K220785 | Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-09-27 |
| K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 ... | Cipher Surgical Limited | 2022-08-19 |
| K221177 | Erbe's Tubing/Cap Sets | Erbe USA, Inc. | 2022-08-11 |
| K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series | Chongqing Jinshan Science & Technology Co., Ltd. | 2021-10-20 |
| K203350 | ENDOtube | Nissha Medical Technologies Sas | 2021-09-29 |
| K202616 | ClearCap Distal Attachment | Finemedix Co., Ltd. | 2021-02-19 |
| K202560 | AquaPulse Irrigation Tubing | Ga Health Company Limited | 2020-12-10 |
| K200479 | AquaPulse Auxiliary Water Connector | Ga Health Company Limited | 2020-05-15 |
| K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector | Ga Health Company Limited | 2020-04-14 |
| K193250 | Irrigation Tubing with CO2 or Air | Keymed (Medical and Industrial Equipment) , Ltd. | 2020-04-06 |
| K193036 | C2 CryoBalloon EndoGrip | Pentax Medical, A Division of Pentax of America, Inc. | 2019-11-22 |
| K191366 | Vacutore Air/Water Bottle Tubing | Smartdata Suzhou Co., Ltd. | 2019-09-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809327356195 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2026-03-24 |
| 08809327356188 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2026-03-24 |
| 08809327356171 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2026-03-24 |
| 08809327356164 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2026-03-24 |
| 08809327356157 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2026-03-24 |
| 08809327356140 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2026-03-24 |
| 08809327356133 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2026-03-24 |
| M710TCW51000 | Bayou™ troCarWash System Disposable Kit | BIOTEX, INC. | 2025-10-10 |
| 14953170458429 | SINGLE USE BIOPSY VALVE | OLYMPUS MEDICAL SYSTEMS CORP. | 2025-09-30 |
| M78312011110 | Diversatek Healthcare | DIVERSATEK HEALTHCARE, INC. | 2025-01-10 |
| M710TCWC0 | Bayou™ troCarWash System Controller | BIOTEX, INC. | 2024-01-22 |
| 08809327352838 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2021-03-11 |
| 08809327350636 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2021-03-11 |
| 08809327352807 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2021-03-11 |
| 08809327352814 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2021-03-11 |
| 08809327352852 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2021-03-11 |
| 08809327352845 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2021-03-11 |
| 08809327352821 | ClearCap Distal Attachment | FINEMEDIX CO.,LTD. | 2021-03-11 |
| 10888277085657 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-05-18 |
| 10888277085664 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-05-18 |
| 10653405986485 | CleanGuard | Conmed Corporation | 2020-04-15 |
| 10724995183490 | BioShield | US Endoscopy | 2020-03-19 |
| 10724995183537 | BioShield | US Endoscopy | 2020-03-19 |
| 10724995183544 | BioShield | US Endoscopy | 2020-03-19 |
| 08714729991144 | OrcaPod™ | BOSTON SCIENTIFIC CORPORATION | 2019-06-14 |
| 08714729981558 | OrcaPod™ | BOSTON SCIENTIFIC CORPORATION | 2018-10-22 |
| 08714729981596 | Seal® | BOSTON SCIENTIFIC CORPORATION | 2018-10-22 |
| 08714729981572 | OrcaPod™ | BOSTON SCIENTIFIC CORPORATION | 2018-10-22 |
| M7831203051 | BullDog® | DIVERSATEK HEALTHCARE, INC. | 2016-11-15 |
| 08714729858614 | Gateway Advantage | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |