Disposable Stone Extraction basket
FDA 510(k) K201509 · Hangzhou AGS MedTech Co., Ltd.
510(k) numberK201509
Submission
- Device name
- Disposable Stone Extraction basket
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
Hangzhou, CN - Received
- June 5, 2020
- Decision date
- December 16, 2020
- 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 |
|---|---|---|---|
| K253056 | Disposable Stone Extraction BasketLQR · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 04/03/2026SE |
| 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 |
| 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 |
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|---|---|---|
| K254069 | Hemoclip (511 series, 543 series)PKL · Traditional | 08/10/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | 06/24/2026SE |
| K252270 | HemoclipPKL · Traditional | 04/08/2026SE |
| K252271 | HemoclipPKL · Traditional | 11/12/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | 03/20/2025SE |
| K222421 | SphincterotomeKNS · Traditional | 05/03/2023SE |
| K221713 | Polypectomy SnareFDI · Traditional | 03/03/2023SE |
| K213143 | HemoclipPKL · Traditional | 07/12/2022SE |
| K213578 | Balloon Dilatation CatheterFDF · Traditional | 04/06/2022SE |
| K211787 | HemoclipPKL · Traditional | 03/03/2022SE |
Questions and answers
When was Disposable Stone Extraction basket cleared by the FDA?
Disposable Stone Extraction basket (K201509) received a 510(k) decision of Substantially Equivalent on December 16, 2020, 194 days after the submission was received.
What is the product code of K201509?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.