Model #27224P Continuous Flow Pump
FDA 510(k) K832009 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK832009
Submission
- Device name
- Model #27224P Continuous Flow Pump
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Mchenry, IL, US - Received
- June 23, 1983
- Decision date
- July 18, 1983
- 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.
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| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
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| 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 |
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| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
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Questions and answers
When was Model #27224P Continuous Flow Pump cleared by the FDA?
Model #27224P Continuous Flow Pump (K832009) received a 510(k) decision of Substantially Equivalent on July 18, 1983, 25 days after the submission was received.
What is the product code of K832009?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.