Mentor Percutaneous Renal Dilator Set
FDA 510(k) K850355 · Mentor Corp.
510(k) numberK850355
Submission
- Device name
- Mentor Percutaneous Renal Dilator Set
- Applicant
- Mentor Corp.
Goleta, CA, US - Received
- January 30, 1985
- Decision date
- March 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EZN – Dilator, Catheter, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5470
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation CatheterEZN · Traditional | Urotronic, Inc. | 05/22/2025SE |
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal…EZN · Traditional | Allwin Medical Devices, Inc. | 05/05/2023SE |
| K201007 | In-Ka Ureteral Balloon Dilatation CatheterEZN · Traditional | Coloplast Corp. | 06/11/2020SESK |
| K190612 | EQUINOX Balloon Dilatation CatheterEZN · Traditional | Dornier Medtech America, Inc. | 12/06/2019SE |
| K173654 | Ureteral Dilator Sets, Ureteral DilatorsEZN · Traditional | Cook Incorporated | 07/17/2018SE |
| K180756 | Safety Wire Guide IntroducerEZN · Traditional | Cook Incorporated | 05/24/2018SE |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer SetEZN · Traditional | Cook Incorporated | 05/02/2018SE |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator SetEZN · Traditional | Cook Incorporated | 04/19/2018SESK |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy DilatorsEZN · Traditional | Coloplast Corp. | 08/17/2017SE |
| K132181 | Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterEZN · Traditional | Olympus Surgical Technologies America | 10/21/2013SE |
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| K062421 | Mentor Resterilizable Gel Breast Implant SizerMRD · Traditional | 10/10/2006SE |
| K053414 | Mentor Novasilk MeshOTP · Traditional | 12/27/2005SE |
| K053296 | Mentor Aris Suprapubic Surgical KitOTN · Traditional | 12/15/2005SE |
| K052440 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Special | 10/11/2005SE |
| K050008 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Traditional | 06/03/2005SE |
| K050148 | Mentor Aris Trans-Obturator Tape and Surgical KitOTN · Traditional | 03/09/2005SE |
| K042851 | Mentor Obtape Trans-Obturator Surgical KitOTN · Special | 11/09/2004SE |
| K040959 | Mentor Genesis Penile ProsthesisFAE · Traditional | 10/29/2004SE |
| K031767 | Mentor Obtape Trans-Obturator TapeOTN · Traditional | 07/17/2003SE |
Questions and answers
When was Mentor Percutaneous Renal Dilator Set cleared by the FDA?
Mentor Percutaneous Renal Dilator Set (K850355) received a 510(k) decision of Substantially Equivalent on March 12, 1985, 41 days after the submission was received.
What is the product code of K850355?
The FDA product code is EZN – Dilator, Catheter, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.5470.