Wiltek Balloon Stone Extractor
FDA 510(k) K894865 · Wiltek Medical, Inc.
510(k) numberK894865
Submission
- Device name
- Wiltek Balloon Stone Extractor
- Applicant
- Wiltek Medical, Inc.
Winston-Salem, NC, US - Received
- July 31, 1989
- Decision date
- December 21, 1989
- 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 |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990231 | Wiltek Hot Biopsy ForcepsKGE · Traditional | 04/13/1999SE |
| K922989 | Wiltek Irrigaiton/Aspiration Tube SetBYY · Traditional | 02/15/1994SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | 06/01/1993SE |
| K914882 | Wiltek Balloon Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914881 | Wiltek Laparoscopic Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914132 | Wiltek Electrocautery Active CordGEI · Traditional | 09/25/1991SE |
| K914131 | Wiltek Electrocautery AdaptorGEI · Traditional | 09/25/1991SE |
| K912288 | Wiltek Standard Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K912122 | Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K910334 | Electrocautery ProbeGEI · Traditional | 02/21/1991SE |
Questions and answers
When was Wiltek Balloon Stone Extractor cleared by the FDA?
Wiltek Balloon Stone Extractor (K894865) received a 510(k) decision of Substantially Equivalent on December 21, 1989, 143 days after the submission was received.
What is the product code of K894865?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.