Irri-Flo Irrigation Delivery System
FDA 510(k) K891339 · Surgitek
510(k) numberK891339
Submission
- Device name
- Irri-Flo Irrigation Delivery System
- Applicant
- Surgitek
Racine, WI, US - Received
- March 10, 1989
- Decision date
- June 2, 1989
- 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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| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/08/2023SE |
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| K930733 | Ureteral StentFAD · Traditional | 07/23/1993SE |
| K930483 | Ureteral CatheterEYB · Traditional | 07/16/1993SESK |
| K926344 | Hydrophilic Coated GuidewireKNY · Traditional | 03/05/1993SE |
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Questions and answers
When was Irri-Flo Irrigation Delivery System cleared by the FDA?
Irri-Flo Irrigation Delivery System (K891339) received a 510(k) decision of Substantially Equivalent on June 2, 1989, 84 days after the submission was received.
What is the product code of K891339?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.