510(k) K171915
- Device
- Nathanson Transcystic Bile Duct Stone Exploration Pack
- Applicant
- Cook Incorporated
- 510(k) number
- K171915
- Product code
- LQR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-01
- Date received
- 2017-06-26
- Regulation
- 876.5010
- Classification name
- Dislodger, Stone, Biliary
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Colin Jacob
- Address
- 450 Daniels Way, P.O. Box 489 Bloomington IN US 47402 47402
FDA Registration Numbers#
- 1037905
- 3021632375
- 3013557562
- 3030447506
- 2431166
- 3011137372
- 9610617
- 3043337628
- 8010047
- 3013440400
- 3010202439
- 1222168
- 2020550
- 3002807314
- 3004837686
- 9681260
- 1320894
- 3013526170
- 9614641
- 3010041511
- 1223925
- 3005099803
- 3005987240
- 3014342096
- 1000393132
- 3003898360
- 3016678045
- 1828132
- 1000121056
- 3010273872
- 3020746799
- 1820334
- 3007695959
- 3008040402
- 3014479313
- 3010288205
- 3014769442
- 3010707607
- 3015895045
- 3025311469
- 3030733800
Source Documents#
Other 510(k) Records For Product Code LQR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253056 | Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-04-03 |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. | 2025-03-18 |
| K243471 | Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | 2024-12-16 |
| K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | 2024-10-15 |
| K230598 | Stone Extraction Baskets | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2023-09-12 |
| K203322 | SpyGlass Discover Retrieval Basket | Boston Scientific Corporation | 2021-05-26 |
| K201509 | Disposable Stone Extraction basket | Hangzhou AGS MedTech Co., Ltd. | 2020-12-16 |
| K191789 | Stonetome Stone Removal Device | Boston Scientific Corporation | 2019-07-25 |
| K182381 | Wilson-Cook Mini Basket | Wilson-Cook Medical, Inc. | 2018-10-30 |
| 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. | 2018-03-28 |
| K173687 | Strange Bile Duct Stone Exploration Set | Cook Incorporated | 2017-12-15 |
| K170898 | Wittich Nitinol Stone Basket | Cook Incorporated | 2017-12-12 |
| K170811 | Single Use Retrieval Nitinol Basket V | Olympus Medical Systems Corp. | 2017-11-27 |
| K173009 | NCompass Nitinol Stone Extractors | Cook Incorporated | 2017-11-07 |
| K131642 | RSH BILIARY STONE REMOVAL DEVICE | Rsh, LLC | 2013-08-07 |
Legacy Summary#
summary
FDA Review#
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