Single use stone retrieval balloons
FDA 510(k) K253132 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
510(k) numberK253132
Submission
- Device name
- Single use stone retrieval balloons
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hangzhou, CN - Received
- September 25, 2025
- Decision date
- March 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code FGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium)FGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/27/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 06/24/2026SE |
| K253832 | Dilation Balloon CatheterFGE · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/24/2026SE |
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | Medi-Globe GmbH | 04/16/2026SE |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235)FGE · Traditional | GIE Medical | 03/13/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | Taewoong Medical Co., Ltd. | 12/29/2025SESU |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | Bioteque Corporation | 12/22/2025SE |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional | Olympus Medical Systems Corporation | 10/21/2025SE |
| K251229 | EndoFixTissue Fixation SystemFGE · Traditional | Softac Medical Technologies | 08/20/2025SE |
| K243412 | ARCHIMEDES Biodegradable Pancreatic StentFGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/16/2025SE |
More from Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
| 510(k) | Device | Decision |
|---|---|---|
| K260410 | Single Use Ureteral Access SheathFED · Special | 09/11/2026SE |
| K251890 | Disposable Ureteral StentsFAD · Traditional | 02/20/2026SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | 09/08/2023SE |
| K220063 | Single Use Cytology BrushFDX · Traditional | 07/28/2022SE |
| K212669 | Single Use HemoclipPKL · Traditional | 05/27/2022SE |
| K220065 | Single Use Ureteral Access SheathFED · Traditional | 05/25/2022SE |
| K212668 | Sclerotherapy NeedleFBK · Traditional | 02/23/2022SE |
| K191900 | Single Use Grasping ForcepsOCZ · Traditional | 03/27/2020SE |
| K192258 | Disposable Valve SetsODC · Traditional | 12/30/2019SE |
Questions and answers
When was Single use stone retrieval balloons cleared by the FDA?
Single use stone retrieval balloons (K253132) received a 510(k) decision of Substantially Equivalent on March 6, 2026, 162 days after the submission was received.
What is the product code of K253132?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.