Entrac(Tm) Urethral Measuring Catheter
FDA 510(k) K914905 · American Medical Systems, Inc.
510(k) numberK914905
Submission
- Device name
- Entrac(Tm) Urethral Measuring Catheter
- Applicant
- American Medical Systems, Inc.
Minnetonka, MN, US - Received
- November 1, 1991
- Decision date
- March 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBM – Catheter, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
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Questions and answers
When was Entrac(Tm) Urethral Measuring Catheter cleared by the FDA?
Entrac(Tm) Urethral Measuring Catheter (K914905) received a 510(k) decision of Substantially Equivalent on March 20, 1992, 140 days after the submission was received.
What is the product code of K914905?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.