Waters Ileostomy Valve
FDA 510(k) K813585 · Waters Instruments, Inc.
510(k) numberK813585
Submission
- Device name
- Waters Ileostomy Valve
- Applicant
- Waters Instruments, Inc.
Mchenry, IL, US - Received
- December 28, 1981
- Decision date
- April 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K834408 | TX-2 Thermal Dilution Cardiac OutputDXG · Traditional | 08/23/1984SE |
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Questions and answers
When was Waters Ileostomy Valve cleared by the FDA?
Waters Ileostomy Valve (K813585) received a 510(k) decision of Substantially Equivalent on April 9, 1982, 102 days after the submission was received.
What is the product code of K813585?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.