Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
FDA 510(k) K232752 · Jiangsu Vedkang Medical Science and Technology Co., Ltd.
510(k) numberK232752
Submission
- Device name
- Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Changzhou, CN - Received
- September 8, 2023
- Decision date
- February 26, 2024
- Decision
- Substantially Equivalent (SESE)
- 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 |
| 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 |
| K173414 | Advance Biliary Balloon CatheterGCA · Traditional | Cook Incorporated | 06/22/2018SESK |
| 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 |
|---|---|---|
| K232825 | Disposable SphincterotomeKNS · Traditional | 03/29/2024SE |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter)FGE · Traditional | 02/15/2024SE |
| K230598 | Stone Extraction BasketsLQR · Traditional | 09/12/2023SE |
| K222146 | Disposable Endoscopic HemoclipPKL · Traditional | 03/28/2023SE |
| K220089 | Disposable Polyp SnareFDI · Traditional | 09/22/2022SE |
| K213914 | Injection NeedleFBK · Traditional | 07/29/2022SE |
Questions and answers
When was Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) cleared by the FDA?
Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) (K232752) received a 510(k) decision of Substantially Equivalent on February 26, 2024, 171 days after the submission was received.
What is the product code of K232752?
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.