Data / Medical devices / Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection / United States
FDA-registered makers of Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA). 9 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Product code
- GCA
- Country
- United States
Makers of Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection in the United States
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | Chaska, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.