No Profile Olbert Catheter System for Urology
FDA 510(k) K905181 · Meadox Surgimed, Inc.
510(k) numberK905181
Submission
- Device name
- No Profile Olbert Catheter System for Urology
- Applicant
- Meadox Surgimed, Inc.
Oakland, NJ, US - Received
- November 19, 1990
- Decision date
- March 6, 1991
- 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 |
More from Olympus Surgical Technologies America
| 510(k) | Device | Decision |
|---|---|---|
| K944143 | MS Classique Balloon CatheterFGE · Traditional | 03/13/1995SE |
| K945061 | Noprofile Olbert Catheter SystemKOD · Traditional | 03/09/1995SE |
| K942382 | MS Amplatz Extra Stiff Guide WireDQX · Traditional | 08/22/1994SE |
| K930201 | Acecut Sutomatic Biopsy SystemKNW · Traditional | 06/09/1993SE |
| K911635 | Meadox(R) Surgimed(R) Biopsy Gun IIKNW · Traditional | 06/20/1991SE |
| K904582 | Quickwire - Hydrophilic Coated GuidewireDQX · Traditional | 02/25/1991SE |
| K904983 | Meadox(R) Surgimed Olbert Cath Syst for UrologyEZN · Traditional | 01/30/1991SE |
| K902461 | Meadox Surgimed Biopsy Gun and NeedleKNW · Traditional | 07/16/1990SE |
| K890926 | Surecut BMB Bone Marrow Biopsy/Aspiration NeedleFMI · Traditional | 06/20/1989SE |
| K863218 | Cytostatic Filtration SetLFK · Traditional | 02/12/1987SE |
Questions and answers
When was No Profile Olbert Catheter System for Urology cleared by the FDA?
No Profile Olbert Catheter System for Urology (K905181) received a 510(k) decision of Substantially Equivalent on March 6, 1991, 107 days after the submission was received.
What is the product code of K905181?
The FDA product code is EZN – Dilator, Catheter, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.5470.