Cysto-Aid
FDA 510(k) K841197 · E-Z-Em, Inc.
510(k) numberK841197
Submission
- Device name
- Cysto-Aid
- Applicant
- E-Z-Em, Inc.
Mchenry, IL, US - Received
- March 21, 1984
- Decision date
- July 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Cysto-Aid cleared by the FDA?
Cysto-Aid (K841197) received a 510(k) decision of Substantially Equivalent on July 9, 1984, 110 days after the submission was received.
What is the product code of K841197?
The FDA product code is KNX – Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.