Disposable Stone Extraction Basket
FDA 510(k) K253056 · Zhejiang Soudon Medical Technology Co., Ltd.
510(k) numberK253056
Submission
- Device name
- Disposable Stone Extraction Basket
- Applicant
- Zhejiang Soudon Medical Technology Co., Ltd.
Hangzhou, CN - Received
- September 22, 2025
- Decision date
- April 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LQR – Dislodger, Stone, Biliary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432PLQR · Traditional | Olympus Medical Systems Corp. | 03/18/2025SE |
| K243471 | Extraction BasketLQR · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 12/16/2024SE |
| K240192 | Single-use Extraction BasketsLQR · Traditional | Scivita Medical Technology Co., Ltd. | 10/15/2024SE |
| K230598 | Stone Extraction BasketsLQR · Traditional | Jiangsu Vedkang Medical Science and Technology… | 09/12/2023SE |
| K203322 | SpyGlass Discover Retrieval BasketLQR · Traditional | Boston Scientific Corporation | 05/26/2021SE |
| K201509 | Disposable Stone Extraction basketLQR · Traditional | Hangzhou AGS MedTech Co., Ltd. | 12/16/2020SE |
| K191789 | Stonetome Stone Removal DeviceLQR · Special | Boston Scientific Corporation | 07/25/2019SESK |
| K182381 | Wilson-Cook Mini BasketLQR · Traditional | Wilson-Cook Medical, Inc. | 10/30/2018SE |
| K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5…LQR · Traditional | Wilson-Cook Medical, Inc. | 03/28/2018SE |
| K171915 | Nathanson Transcystic Bile Duct Stone Exploration PackLQR · Traditional | Cook Incorporated | 03/01/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K253013 | Disposable Stone Retrieval Balloon CatheterGCA · Traditional | 05/08/2026SE |
| K232450 | Disposable Hemostatic ClipsPKL · Traditional | 01/26/2024SE |
| K232442 | Disposable Endoscope Injection NeedlesFBK · Traditional | 11/09/2023SE |
| K232476 | Disposable SphincterotomeKNS · Traditional | 11/07/2023SE |
Questions and answers
When was Disposable Stone Extraction Basket cleared by the FDA?
Disposable Stone Extraction Basket (K253056) received a 510(k) decision of Substantially Equivalent on April 3, 2026, 193 days after the submission was received.
What is the product code of K253056?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.