Air Water Source (Acmi Model 710)
FDA 510(k) K760451 · American Cystocope Makers, Inc.
510(k) numberK760451
Submission
- Device name
- Air Water Source (Acmi Model 710)
- Applicant
- American Cystocope Makers, Inc.
Mchenry, IL, US - Received
- August 16, 1976
- Decision date
- August 30, 1976
- 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 |
|---|---|---|
| K832040 | Sterile Fluid Producing Unit #EP550LJH · Traditional | 09/29/1983SE |
| K812637 | Acmi Bipolar Hemostatic SourceGEI · Traditional | 10/26/1981SE |
| K811218 | Acmi Aspirator Kit #8808EOQ · Traditional | 07/01/1981SE |
| K803214 | Acmi Bipolar Hemostatic ElectrodeFEH · Traditional | 01/15/1981SE |
| K791182 | Acmi Rigi-Flex NephorscopeFGA · Traditional | 07/30/1979SE |
| K770754 | Duodenoscope, Molel TX-6FOG · Traditional | 04/28/1977SE |
| K760822 | Model TX-8 PanendoscopeFAK · Traditional | 10/21/1976SE |
| K760452 | Colonoscope, 2-CHANNEL Log (Acmi TX-92)FDF · Traditional | 08/30/1976SE |
Questions and answers
When was Air Water Source (Acmi Model 710) cleared by the FDA?
Air Water Source (Acmi Model 710) (K760451) received a 510(k) decision of Substantially Equivalent on August 30, 1976, 14 days after the submission was received.
What is the product code of K760451?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.