Tri-Med Endoscopic Fluid Introduction Catheter
FDA 510(k) K942918 · Tri-Med Specialties, Inc.
510(k) numberK942918
Submission
- Device name
- Tri-Med Endoscopic Fluid Introduction Catheter
- Applicant
- Tri-Med Specialties, Inc.
Overland Park, KS, US - Received
- June 21, 1994
- Decision date
- February 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K971615 | Pattison Esophageal DilatorKNQ · Traditional | 07/24/1997SE |
| K970890 | #ES-32 Suction Catheter 32 Fr.KNT · Traditional | 05/23/1997SE |
| K970982 | T-Rx Retrieval ForcepsOCZ · Traditional | 05/09/1997SE |
| K950574 | Needle/CannulaLRO · Traditional | 02/24/1995SEKD |
| K934348 | Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FRBSS · Traditional | 12/23/1994SE |
| K945160 | Paracentesis Needles/CannulasLRO · Traditional | 11/14/1994SE |
| K924549 | Tri-Med Quick-Step(Tm) Rectal TubeGBT · Traditional | 02/10/1994SE |
| K932015 | Tri-Med Inflatable Esophageal DilatorKNQ · Traditional | 02/03/1994SE |
| K932652 | Tri-Med Paracentesis TrayLRO · Traditional | 11/24/1993SEKD |
| K931201 | Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional | 09/28/1993SE |
Questions and answers
When was Tri-Med Endoscopic Fluid Introduction Catheter cleared by the FDA?
Tri-Med Endoscopic Fluid Introduction Catheter (K942918) received a 510(k) decision of Substantially Equivalent on February 28, 1995, 252 days after the submission was received.
What is the product code of K942918?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.