O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
FDA 510(k) K182066 · Cook Incorporated
510(k) numberK182066
Submission
- Device name
- O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- August 1, 2018
- Decision date
- October 30, 2018
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOB – Catheter, Suprapubic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code KOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional | Applied Medical Technology, Inc. | 11/01/2024SE |
| K181097 | Cook Cystostomy Catheter SetKOB · Traditional | Cook Incorporated | 01/18/2019SESK |
| K182709 | One-Step Suprapubic IntroducerKOB · Traditional | Cook Incorporated | 12/26/2018SE |
| K132890 | Suprapubic Catheter and Introducer SetKOB · Traditional | Mediplus , Ltd. | 01/17/2014SE |
| K120127 | Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemKOB · Traditional | Swan Valley Medical, Incorporated | 10/26/2012SE |
| K014002 | All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional | Fortune Medical Instrument Corp. | 03/04/2002SE |
| K012153 | Lowsley Suprapubic TractorKOB · Traditional | Circon Video | 09/19/2001SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | The Kendal Co. | 04/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | Rusch, Inc. | 02/07/1997SE |
| K945480 | Moss(R) Steel Breakaway(R) IntroducerKOB · Traditional | Harry A. Schlakman | 08/28/1995SE |
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| K233177 | Nest VT Vitrification DeviceMQK · Traditional | 03/08/2024SE |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval SetMMX · Traditional | 05/16/2023SE |
| K223098 | Bakri Essential Postpartum BalloonOQY · Special | 10/28/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | 04/06/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | 02/16/2021SE |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
| K190084 | McLean-Ring Enteral Feeding Tube SetKNT · Traditional | 10/11/2019SE |
Questions and answers
When was O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set cleared by the FDA?
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (K182066) received a 510(k) decision of Unknown on October 30, 2018, 90 days after the submission was received.
What is the product code of K182066?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.