Tri-Ex Extraction Balloon With Multiple Sizing
FDA 510(k) K170292 · Wilson-Cook Medical, Inc.
510(k) numberK170292
Submission
- Device name
- Tri-Ex Extraction Balloon With Multiple Sizing
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- January 31, 2017
- Decision date
- September 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K173414 | Advance Biliary Balloon CatheterGCA · Traditional | Cook Incorporated | 06/22/2018SESK |
| K063677 | Fusion Quattro Extraction Balloon XLGCA · Special | Wilson-Cook Medical, Inc. | 01/05/2007SE |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X])QAU · Traditional | 06/02/2026SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | 09/29/2025SE |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordKNS · Special | 01/17/2025SE |
| K213483 | SnapLoc Wire LockODC · Traditional | 04/26/2022SE |
| K213356 | Entuit PEG, Entuit PEGJPIF · Special | 01/20/2022SESD |
| K212323 | Instinct Plus Endoscopic Clipping DevicePKL · Special | 08/25/2021SE |
| K201322 | Entuit Nasal Jejunal Feeding TubeKNT · Special | 06/17/2020SESK |
| K200972 | Hemospray Endoscopic HemostatQAU · Traditional | 06/10/2020SE |
| K200247 | Fusion Quattro Extraction BalloonGCA · Special | 02/27/2020SE |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordKNS · Traditional | 01/30/2020SE |
Questions and answers
When was Tri-Ex Extraction Balloon With Multiple Sizing cleared by the FDA?
Tri-Ex Extraction Balloon With Multiple Sizing (K170292) received a 510(k) decision of Substantially Equivalent on September 20, 2017, 232 days after the submission was received.
What is the product code of K170292?
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.