Data / Medical devices / Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (GCA): 22 FDA-registered makers in 6 countries
22 establishments in 6 countries are registered with the FDA to make Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA, Class 2, 21 CFR 876.5010). 17 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on May 8, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GCA
- Device class
- 2
- Regulation
- 876.5010
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| China | 4 |
| Ireland | 2 |
| Mexico | 2 |
| Malaysia | 1 |
| Taiwan | 1 |
Makers of Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 5 | February 27, 2020 | 0 | 1 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 1 | April 18, 1991 | 0 | 0 | 0 | api.fda.gov |
| Anrei Medical (Hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Manufacturer | 1 | April 27, 2021 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 1 | April 18, 1991 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Medical Device (Malaysia) SDN BHD | Taman Perindustrian Batu Kawan Pulau Pinang, Malaysia | Manufacturer | 1 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Manufacturer | 1 | August 26, 1992 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 1 | June 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Fortune Medical Instrument Corp. | Taoyuan City, Taiwan | Contract manufacturer, Manufacturer | 1 | May 27, 1998 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer, Repackager or relabeler | 1 | May 1, 2020 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | Changzhou Jiangsu, China | Manufacturer | 1 | February 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | June 22, 2001 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | June 22, 2001 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 1 | June 22, 2001 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Soudon Medical Technology Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | May 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical Limited | NEW ROSS Wexford, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical | Chaska, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.