Vnace Fascial Dilator Set
FDA 510(k) K811833 · Vance Products, Inc.
510(k) numberK811833
Submission
- Device name
- Vnace Fascial Dilator Set
- Applicant
- Vance Products, Inc.
- Received
- June 30, 1981
- Decision date
- July 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K191061 | Optilume Basic Urological Balloon Dilation CatheterKOE · Traditional | Urotronic, Inc. | 01/02/2020SE |
| 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 |
More from Peripheral Systems Group
| 510(k) | Device | Decision |
|---|---|---|
| K820313 | Vpi-Fair Urethral StentKOD · Traditional | 03/01/1982SE |
| K812995 | Vance-Jacobellis Microhematuria CatheterKOD · Traditional | 03/01/1982SE |
| K813278 | Vpi Ureteral Dilatation Ballon CatheterEZN · Traditional | 12/18/1981SE |
| K812785 | Vance-Ambrose Resectoscope ForcepsGEN · Traditional | 11/16/1981SE |
| K812057 | Vance CystoscopicFBK · Traditional | 07/31/1981SE |
| K811454 | Vance Prostatic Aspiration SetKNW · Traditional | 06/09/1981SE |
| K810372 | Vance Deflectable Biopsy Brush SetKOD · Traditional | 03/20/1981SE |
| K810371 | Vance Urethal Dilator SetKOE · Traditional | 03/20/1981SE |
| K810370 | Pollack Chain Cysourethrogram SetFGI · Traditional | 03/20/1981SE |
| K810368 | Vance Percutaneous Malecot NephrostomyKOB · Traditional | 03/20/1981SE |
Questions and answers
When was Vnace Fascial Dilator Set cleared by the FDA?
Vnace Fascial Dilator Set (K811833) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 10 days after the submission was received.
What is the product code of K811833?
The FDA product code is KOE – Dilator, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5520.