Noprofile Olbert Catheter System
FDA 510(k) K945061 · Meadox Surgimed, Inc.
510(k) numberK945061
Submission
- Device name
- Noprofile Olbert Catheter System
- Applicant
- Meadox Surgimed, Inc.
Oakland, NJ, US - Received
- October 14, 1994
- Decision date
- March 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional | Cook Incorporated | 03/07/2018SE |
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More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K944143 | MS Classique Balloon CatheterFGE · Traditional | 03/13/1995SE |
| 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 |
| K905181 | No Profile Olbert Catheter System for UrologyEZN · Traditional | 03/06/1991SE |
| 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 Noprofile Olbert Catheter System cleared by the FDA?
Noprofile Olbert Catheter System (K945061) received a 510(k) decision of Substantially Equivalent on March 9, 1995, 146 days after the submission was received.
What is the product code of K945061?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.