LQR · Dislodger, Stone, Biliary
Gastroenterology, Urology · 21 CFR 876.5010 · Class 2
Overview
| Product Code | LQR |
|---|---|
| Device Name | Dislodger, Stone, Biliary |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
Classification Rationale
Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253056 | Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. | Apr 3, 2026 | SESE |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. | Mar 18, 2025 | SESE |
| K243471 | Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | Dec 16, 2024 | SESE |
| K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | Oct 15, 2024 | SESE |
| K230598 | Stone Extraction Baskets | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Sep 12, 2023 | SESE |
| K203322 | SpyGlass Discover Retrieval Basket | Boston Scientific Corporation | May 26, 2021 | SESE |
| K201509 | Disposable Stone Extraction basket | Hangzhou AGS MedTech Co., Ltd. | Dec 16, 2020 | SESE |
| K191789 | Stonetome Stone Removal Device | Boston Scientific Corporation | Jul 25, 2019 | SESK |
| K182381 | Wilson-Cook Mini Basket | Wilson-Cook Medical, Inc. | Oct 30, 2018 | SESE |
| K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket | Wilson-Cook Medical, Inc. | Mar 28, 2018 | SESE |
| K171915 | Nathanson Transcystic Bile Duct Stone Exploration Pack | Cook Incorporated | Mar 1, 2018 | SESE |
| K173687 | Strange Bile Duct Stone Exploration Set | Cook Incorporated | Dec 15, 2017 | SESK |
| K170898 | Wittich Nitinol Stone Basket | Cook Incorporated | Dec 12, 2017 | SESE |
| K170811 | Single Use Retrieval Nitinol Basket V | Olympus Medical Systems Corp. | Nov 27, 2017 | SESE |
| K173009 | NCompass Nitinol Stone Extractors | Cook Incorporated | Nov 7, 2017 | SESE |
| K131642 | RSH BILIARY STONE REMOVAL DEVICE | Rsh, LLC | Aug 7, 2013 | SESE |
| K091495 | SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A | Olympus Medical Systems Corporation | Sep 3, 2009 | SESE |
| K090485 | COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 | Percutaneous Systems, Incorporated | Jul 22, 2009 | SESE |
| K071066 | SPYCATCH STONE RETRIEVAL BASKET | Boston Scientific Corp | Jun 29, 2007 | SESE |
| K992941 | LEMAITRE BILIARY CATHETER | Vascutech, Inc. | Jan 12, 2000 | SESE |
Top Applicants
- Boston Scientific Corp — 4 clearances
- Cook Incorporated — 4 clearances
- Wilson-Cook Medical, Inc. — 3 clearances
- Boston Scientific Corporation — 2 clearances
- Cook, Inc. — 2 clearances
