Advance Biliary Balloon Catheter
FDA 510(k) K173414 · Cook Incorporated
510(k) numberK173414
Submission
- Device name
- Advance Biliary Balloon Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- November 1, 2017
- Decision date
- June 22, 2018
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253013 | Disposable Stone Retrieval Balloon CatheterGCA · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 05/08/2026SE |
| K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-…GCA · Traditional | Jiangsu Vedkang Medical Science and Technology… | 02/26/2024SE |
| K212582 | SpyGlass Discover Balloon Dilation CatheterGCA · Traditional | Boston Scientific Corporation | 05/06/2022SE |
| K210660 | Stone Retrieval Balloon CatheterGCA · Traditional | Anrei Medical (Hangzhou) Co., Ltd. | 04/27/2021SE |
| K200173 | Stone Retrieval BalloonGCA · Traditional | Hangzhou AGS MedTech Co., Ltd. | 05/01/2020SE |
| K200247 | Fusion Quattro Extraction BalloonGCA · Special | Wilson-Cook Medical, Inc. | 02/27/2020SE |
| K193344 | Tri-Ex Extraction Balloon with Multiple SizingGCA · Special | Wilson-Cook Medical, Inc. | 12/13/2019SE |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple SizingGCA · Special | Wilson-Cook Medical, Inc. | 07/06/2018SE |
| K170292 | Tri-Ex Extraction Balloon With Multiple SizingGCA · Special | Wilson-Cook Medical, Inc. | 09/20/2017SE |
| K063677 | Fusion Quattro Extraction Balloon XLGCA · Special | Wilson-Cook Medical, Inc. | 01/05/2007SE |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 Advance Biliary Balloon Catheter cleared by the FDA?
Advance Biliary Balloon Catheter (K173414) received a 510(k) decision of Unknown on June 22, 2018, 233 days after the submission was received.
What is the product code of K173414?
The FDA product code is GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, a Class II (moderate risk) device regulated under 21 CFR 876.5010.