Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
FDA 510(k) K243807 · Olympus Medical Systems Corp.
510(k) numberK243807
Submission
- Device name
- Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
- Applicant
- Olympus Medical Systems Corp.
Hachiochi-Shi, JP - Received
- December 11, 2024
- Decision date
- March 18, 2025
- 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
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|---|---|---|---|
| K253056 | Disposable Stone Extraction BasketLQR · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 04/03/2026SE |
| 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 |
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Questions and answers
When was Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P cleared by the FDA?
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (K243807) received a 510(k) decision of Substantially Equivalent on March 18, 2025, 97 days after the submission was received.
What is the product code of K243807?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.