Over the Wire Stone Basket
FDA 510(k) K915538 · Medical Dynamics, Inc.
510(k) numberK915538
Submission
- Device name
- Over the Wire Stone Basket
- Applicant
- Medical Dynamics, Inc.
Englewood, CO, US - Received
- December 10, 1991
- Decision date
- March 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974542 | True Vision, True Vision IIEIA · Traditional | 02/17/1998SE |
| K921294 | Video Endoscope-Rigid ModificationHET · Traditional | 07/20/1994SE |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | 02/15/1994SE |
| K930568 | Adair/Veress Needle Introducer SetGCB · Traditional | 07/22/1993SE |
| K914315 | Optical Catheter Introducer Sets, ModificationKGX · Traditional | 03/04/1992SE |
| K913986 | Cholangiography/Cholangioscopy/Lihopaxy SystemFGE · Traditional | 01/28/1992SESK |
| K911296 | Optical Catheter ArthroscopeHRX · Traditional | 09/24/1991SE |
| K903339 | Video Endoscope, RigidHET · Traditional | 03/06/1991SE |
| K904609 | Xenon Light SourceHBI · Traditional | 12/18/1990SE |
| K904113 | Operative Recording CameraIKO · Traditional | 10/30/1990SE |
Questions and answers
When was Over the Wire Stone Basket cleared by the FDA?
Over the Wire Stone Basket (K915538) received a 510(k) decision of Substantially Equivalent on March 20, 1992, 101 days after the submission was received.
What is the product code of K915538?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.