No. 86500 - Endoscopic Jet Washer
FDA 510(k) K892426 · Superior Healthcare Group, Inc.
510(k) numberK892426
Submission
- Device name
- No. 86500 - Endoscopic Jet Washer
- Applicant
- Superior Healthcare Group, Inc.
Cumberland, RI, US - Received
- April 10, 1989
- Decision date
- June 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- OCX – Endoscopic Irrigation/Suction System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Other 510(k)s with product code OCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251986 | Auxiliary Water Tube MAJ-855OCX · Traditional | Olympus Medical Systems Corporation | 09/26/2025SE |
| K251997 | Single-Use Biopsy Valve (MAJ-1555)OCX · Traditional | Olympus Medical Systems Corporation | 09/25/2025SE |
| K242586 | ArgoCap (200.52)OCX · Traditional | Ovesco Endoscopy AG | 05/22/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | Hangzhou AGS MedTech Co., Ltd. | 03/20/2025SE |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902)OCX · Traditional | Olympus Medical Systems Corporation | 10/07/2024SE |
| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
| K242134 | ClearCap Distal AttachmentOCX · Special | Finemedix Co., Ltd. | 08/20/2024SE |
| K233442 | troCarWash SystemOCX · Traditional | Biotex, Inc. | 05/21/2024SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/08/2023SE |
More from Zhejiang Chuangxiang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K925530 | Instrument WarmerFMS · Traditional | 06/18/1993SE |
| K924764 | Overtube for Endscopic LigatorMNK · Traditional | 03/15/1993SE |
| K905755 | Non-Sterile Patient Examination GlovesLYY · Traditional | 03/08/1991SE |
| K903347 | Sodium Chloride SolutionFOZ · Traditional | 12/13/1990SE |
| K904216 | Sterile Water Solution Catalog # 10000JOL · Traditional | 11/16/1990SE |
| K903340 | Sterile Urethral Catheter Procedure KitsFCM · Traditional | 10/04/1990SESD |
| K896321 | No. 34100 - 8 FR & No. 34400 - 14 FR Closed Trach.BSY · Traditional | 11/13/1989SE |
| K894676 | Sterile Latex Exam GlovesLYY · Traditional | 08/17/1989SE |
| K891445 | Latex Examination GlovesLYY · Traditional | 08/09/1989SE |
| K885339 | Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitKNT · Traditional | 03/01/1989SE |
Questions and answers
When was No. 86500 - Endoscopic Jet Washer cleared by the FDA?
No. 86500 - Endoscopic Jet Washer (K892426) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 73 days after the submission was received.
What is the product code of K892426?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.