FDA product code GCA: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
GCA is the FDA product code for biliary catheter for stone removal that may also allow for irrigation and contrast injection. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 26 510(k) submissions under GCA, 3 in the last five years, from 18 different applicants. The average 510(k) review took 117 days (median 112); 201 days on average over the last three years. FDA has posted 2 recalls for GCA devices.
Classification
| Field | Value |
|---|---|
| Device name | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device class | Class II |
| Regulation | 21 CFR 876.5010 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GCA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 232 |
| 2018 | 2 | 226 |
| 2019 | 1 | 10 |
| 2020 | 2 | 63 |
| 2021 | 1 | 54 |
| 2022 | 1 | 263 |
| 2024 | 1 | 171 |
| 2026 | 1 | 231 |
Compare with all 510(k) review times · Search every GCA clearance
Top GCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wilson-Cook Medical, Inc. | 7 | 2020-02-27 |
| Davol, Inc. | 2 | 1992-03-30 |
| United States Endoscopy Group, Inc. | 2 | 1992-03-06 |
| Zhejiang Soudon Medical Technology Co., Ltd. | 1 | 2026-05-08 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 1 | 2024-02-26 |
13 more applicants have GCA clearances. See the full list in Caduvo.
Most recent GCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253013 | Zhejiang Soudon Medical Technology Co., Ltd. | Disposable Stone Retrieval Balloon Catheter | 2026-05-08 | 231 |
| K232752 | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 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) | 2024-02-26 | 171 |
| K212582 | Boston Scientific Corporation | SpyGlass Discover Balloon Dilation Catheter | 2022-05-06 | 263 |
| K210660 | Anrei Medical (Hangzhou) Co., Ltd. | Stone Retrieval Balloon Catheter | 2021-04-27 | 54 |
| K200173 | Hangzhou AGS MedTech Co., Ltd. | Stone Retrieval Balloon | 2020-05-01 | 99 |
Recalls for GCA devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-11.
Frequently asked questions
What is FDA product code GCA?
GCA is the FDA product code for biliary catheter for stone removal that may also allow for irrigation and contrast injection. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel.
What device class is GCA?
Class II, regulation 21 CFR 876.5010. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCA?
Across 26 cleared submissions the average was 117 days from receipt to decision (median 112).
Which companies have the most GCA clearances?
Wilson-Cook Medical, Inc. (7); Davol, Inc. (2); United States Endoscopy Group, Inc. (2); Zhejiang Soudon Medical Technology Co., Ltd. (1); Jiangsu Vedkang Medical Science and Technology Co., Ltd. (1).
Have GCA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GCA
- Run a recall and safety report across every GCA manufacturer
- Watch product code GCA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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