Optilume Basic Urological Balloon Dilation Catheter
FDA 510(k) K191061 · Urotronic, Inc.
510(k) numberK191061
Submission
- Device name
- Optilume Basic Urological Balloon Dilation Catheter
- Applicant
- Urotronic, Inc.
Minneapolis, MN, US - Received
- April 22, 2019
- Decision date
- January 2, 2020
- 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
Other 510(k)s with product code KOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032840 | Atrion Medical QL Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 03/03/2004SE |
| K972964 | Atrion Medical Balloon Catheter Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 10/10/1997SE |
| K962611 | Bard Eagle Inflation DeviceKOE · Traditional | Ryder Intl. Corp. | 10/21/1996SE |
| 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 |
| K920711 | Entrac Urethral Balloon Dilatation CatheterKOE · Traditional | American Medical Systems, Inc. | 05/06/1992SE |
| 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 |
More from Advanced Surgical Intervention, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation CatheterEZN · Traditional | 05/22/2025SE |
Questions and answers
When was Optilume Basic Urological Balloon Dilation Catheter cleared by the FDA?
Optilume Basic Urological Balloon Dilation Catheter (K191061) received a 510(k) decision of Substantially Equivalent on January 2, 2020, 255 days after the submission was received.
What is the product code of K191061?
The FDA product code is KOE – Dilator, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5520.