Gip/Med-Globe Stone Extractor Baskets
FDA 510(k) K942005 · Medi-Globe Corp.
510(k) numberK942005
Submission
- Device name
- Gip/Med-Globe Stone Extractor Baskets
- Applicant
- Medi-Globe Corp.
Tempe, AZ, US - Received
- April 25, 1994
- Decision date
- November 22, 1994
- 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 |
| 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 |
|---|---|---|
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | 04/16/2026SE |
| K153264 | EasyPass GuidewireOCY · Traditional | 05/19/2016SE |
| K142258 | PolyCatch Retrieval DeviceFDI · Traditional | 09/30/2014SE |
| K133763 | Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemFCG · Traditional | 05/15/2014SE |
| K091257 | Medi-Globe Sonotip II Ebus-Tbna Needle SystemFCG · Traditional | 05/08/2009SE |
| K083802 | Sonotip II 25-GAUGE Ultrasound Needle System, Models GUS-01-18-025 and GUS-01-27-025FCG · Traditional | 03/20/2009SE |
| K070129 | Sonotip II Ultrasound Needle SystemFCG · Traditional | 01/31/2007SE |
| K061222 | Injectra Injection NeedleFBK · Traditional | 07/03/2006SE |
| K061684 | Medi-Globe Rota-Cut SphincterotomeKNS · Traditional | 06/27/2006SE |
| K051247 | Sonotip II Ultrasound Needle SystemFCG · Special | 06/16/2005SE |
Questions and answers
When was Gip/Med-Globe Stone Extractor Baskets cleared by the FDA?
Gip/Med-Globe Stone Extractor Baskets (K942005) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 211 days after the submission was received.
What is the product code of K942005?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.