Stone Extraction Baskets
FDA 510(k) K230598 · Jiangsu Vedkang Medical Science and Technology Co., Ltd.
510(k) numberK230598
Submission
- Device name
- Stone Extraction Baskets
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Changzhou, CN - Received
- March 3, 2023
- Decision date
- September 12, 2023
- 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 |
| 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 |
|---|---|---|
| K232825 | Disposable SphincterotomeKNS · Traditional | 03/29/2024SE |
| K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-…GCA · Traditional | 02/26/2024SE |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter)FGE · Traditional | 02/15/2024SE |
| K222146 | Disposable Endoscopic HemoclipPKL · Traditional | 03/28/2023SE |
| K220089 | Disposable Polyp SnareFDI · Traditional | 09/22/2022SE |
| K213914 | Injection NeedleFBK · Traditional | 07/29/2022SE |
Questions and answers
When was Stone Extraction Baskets cleared by the FDA?
Stone Extraction Baskets (K230598) received a 510(k) decision of Substantially Equivalent on September 12, 2023, 193 days after the submission was received.
What is the product code of K230598?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.