Aspiration Catheter (2189)
FDA 510(k) K241874 · Hobbs Medical, Inc.
510(k) numberK241874
Submission
- Device name
- Aspiration Catheter (2189)
- Applicant
- Hobbs Medical, Inc.
Stafford Springs, CT, US - Received
- June 28, 2024
- Decision date
- September 24, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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.
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| 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 |
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| K242134 | ClearCap Distal AttachmentOCX · Special | Finemedix Co., Ltd. | 08/20/2024SE |
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| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/08/2023SE |
| K231418 | ENDOGATOR Hybrid Irrigation TubingOCX · Traditional | Medivators | 08/14/2023SE |
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Questions and answers
When was Aspiration Catheter (2189) cleared by the FDA?
Aspiration Catheter (2189) (K241874) received a 510(k) decision of Substantially Equivalent on September 24, 2024, 88 days after the submission was received.
What is the product code of K241874?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.