Entrac Urethral Balloon Dilatation Catheter
FDA 510(k) K920711 · American Medical Systems, Inc.
510(k) numberK920711
Submission
- Device name
- Entrac Urethral Balloon Dilatation Catheter
- Applicant
- American Medical Systems, Inc.
Minnetonka, MN, US - Received
- February 18, 1992
- Decision date
- May 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOE – Dilator, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5520
- Specialty
- Gastroenterology, Urology
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| K972964 | Atrion Medical Balloon Catheter Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 10/10/1997SE |
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| K961904 | Aq Hydrophilic DilatorsKOE · Traditional | Cook Urological, Inc. | 10/18/1996SE |
| K924440 | U.S. Medical PS-7000 Dialysis ScaleKOE · Traditional | U.S. Medical Corp. | 05/26/1993SE |
| K920551 | 120 FR Optilume Prostate Balloon DilatorKOE · Traditional | American Medical Systems, Inc. | 10/28/1992SE |
| K922349 | Dowd(Tm) IIKOE · Traditional | Boston Scientific Corp | 08/14/1992SE |
| K913477 | Apex(Tm) Prostatic Balloon Dilation CatheterKOE · Traditional | Peripheral Systems Group | 12/27/1991SE |
| K902585 | Uroplasty Tcu Prostatic Urethroplasty CatheterKOE · Traditional | Advanced Surgical Intervention, Inc. | 08/27/1990SE |
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Questions and answers
When was Entrac Urethral Balloon Dilatation Catheter cleared by the FDA?
Entrac Urethral Balloon Dilatation Catheter (K920711) received a 510(k) decision of Substantially Equivalent on May 6, 1992, 78 days after the submission was received.
What is the product code of K920711?
The FDA product code is KOE – Dilator, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5520.