Hobbs Medical/Jayco Aspiration Catheter
FDA 510(k) K844550 · Hobbs Medical, Inc.
510(k) numberK844550
Submission
- Device name
- Hobbs Medical/Jayco Aspiration Catheter
- Applicant
- Hobbs Medical, Inc.
Palmer, MA, US - Received
- November 21, 1984
- Decision date
- January 3, 1985
- 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 |
|---|---|---|
| K241874 | Aspiration Catheter (2189)OCX · Traditional | 09/24/2024SE |
| K182927 | Pulmonary Cytology BrushBTG · Traditional | 02/07/2020SE |
| K093079 | Touchsoft Coagulator with Banana Fitting, Model 4581 and with Universal Fitting, Model…KNS · Traditional | 08/02/2010SE |
| K030765 | Hobbs Mistifier Spray CatheterOCX · Traditional | 06/09/2003SE |
| K933354 | Hobbs Medical Cleaning BrushFEB · Traditional | 10/28/1993SE |
| K922396 | Fujinon Forceps -- ModificationFCL · Traditional | 12/10/1992SE |
| K921026 | Pressure GaugeKNT · Traditional | 04/24/1992SE |
| K914358 | Encapsulated Guidewire with Flexible TipEYB · Traditional | 11/19/1991SE |
| K893729 | Hobbs Medical Microbiology BrushFDX · Traditional | 08/28/1989SE |
| K872509 | Linden Stone Extraction BalloonFGE · Traditional | 09/22/1987SE |
Questions and answers
When was Hobbs Medical/Jayco Aspiration Catheter cleared by the FDA?
Hobbs Medical/Jayco Aspiration Catheter (K844550) received a 510(k) decision of Substantially Equivalent on January 3, 1985, 43 days after the submission was received.
What is the product code of K844550?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.