Hobbs Mistifier Spray Catheter
FDA 510(k) K030765 · Hobbs Medical, Inc.
510(k) numberK030765
Submission
- Device name
- Hobbs Mistifier Spray Catheter
- Applicant
- Hobbs Medical, Inc.
Stafford Springs, CT, US - Received
- March 11, 2003
- Decision date
- June 9, 2003
- 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.
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| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
| 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 |
More from Zhejiang Chuangxiang Medical Technology Co., Ltd.
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|---|---|---|
| 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 |
| 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 |
| K860593 | Et/Rt PapillotomeKNS · Traditional | 07/22/1986SE |
Questions and answers
When was Hobbs Mistifier Spray Catheter cleared by the FDA?
Hobbs Mistifier Spray Catheter (K030765) received a 510(k) decision of Substantially Equivalent on June 9, 2003, 90 days after the submission was received.
What is the product code of K030765?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.