Assure-Male External Incontince Catheter
FDA 510(k) K821848 · Medical Design & Manufacturing Corp.
510(k) numberK821848
Submission
- Device name
- Assure-Male External Incontince Catheter
- Applicant
- Medical Design & Manufacturing Corp.
Mchenry, IL, US - Received
- June 22, 1982
- Decision date
- August 10, 1982
- 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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| K880492 | Intercept T.E.N.S. DeviceGZJ · Traditional | 04/18/1988SE |
| K834138 | Hypo SutureGAG · Traditional | 01/27/1984SE |
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Questions and answers
When was Assure-Male External Incontince Catheter cleared by the FDA?
Assure-Male External Incontince Catheter (K821848) received a 510(k) decision of Substantially Equivalent on August 10, 1982, 49 days after the submission was received.
What is the product code of K821848?
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.