Single-use Extraction Baskets
FDA 510(k) K240192 · Scivita Medical Technology Co., Ltd.
510(k) numberK240192
Submission
- Device name
- Single-use Extraction Baskets
- Applicant
- Scivita Medical Technology Co., Ltd.
Suzhou, CN - Received
- January 24, 2024
- Decision date
- October 15, 2024
- 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 |
| 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 |
|---|---|---|
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | 08/14/2026SE |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…FBN · Traditional | 01/20/2026SE |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…FGB · Traditional | 03/27/2025SE |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…EOQ · Special | 03/19/2025SE |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)EOQ · Traditional | 10/23/2024SE |
| K231521 | Broncho Videoscope SystemEOQ · Traditional | 11/14/2023SE |
| K222812 | InsufflatorHIF · Traditional | 05/16/2023SE |
| K221252 | Scivita 4KINSIGHT ICG Imaging SystemGCJ · Traditional | 01/13/2023SE |
| K210379 | Broncho Videoscope SystemEOQ · Traditional | 07/28/2021SE |
| K203255 | 4K UHD LaparoscopeGCJ · Traditional | 02/24/2021SE |
Questions and answers
When was Single-use Extraction Baskets cleared by the FDA?
Single-use Extraction Baskets (K240192) received a 510(k) decision of Substantially Equivalent on October 15, 2024, 265 days after the submission was received.
What is the product code of K240192?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.