Glassman Stone Extraction Set
FDA 510(k) K904472 · Wilson-Cook Medical, Inc.
510(k) numberK904472
Submission
- Device name
- Glassman Stone Extraction Set
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- October 1, 1990
- Decision date
- December 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| 510(k) | Device | Decision |
|---|---|---|
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| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordKNS · Special | 01/17/2025SE |
| K213483 | SnapLoc Wire LockODC · Traditional | 04/26/2022SE |
| K213356 | Entuit PEG, Entuit PEGJPIF · Special | 01/20/2022SESD |
| K212323 | Instinct Plus Endoscopic Clipping DevicePKL · Special | 08/25/2021SE |
| K201322 | Entuit Nasal Jejunal Feeding TubeKNT · Special | 06/17/2020SESK |
| K200972 | Hemospray Endoscopic HemostatQAU · Traditional | 06/10/2020SE |
| K200247 | Fusion Quattro Extraction BalloonGCA · Special | 02/27/2020SE |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordKNS · Traditional | 01/30/2020SE |
Questions and answers
When was Glassman Stone Extraction Set cleared by the FDA?
Glassman Stone Extraction Set (K904472) received a 510(k) decision of Substantially Equivalent on December 28, 1990, 88 days after the submission was received.
What is the product code of K904472?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.