Atlas FDA

Stonetome Stone Removal Device

FDA 510(k) clearance K191789 · decided 2019-07-25

Clearance details

K-number
K191789
Device name
Stonetome Stone Removal Device
Applicant
Boston Scientific Corporation
Decision
Unknown
Date received
2019-07-03
Decision date
2019-07-25
Days to decision
22 days
Clearance type
Special
Product code
LQR
Device class
2
Regulation number
876.5010
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Disposable Stone Extraction Basket (K253056)Zhejiang Soudon Medical Technology Co., Ltd.2026-04-03
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Extraction Basket (K243471)Micro-Tech (Nanjing) Co., Ltd.2024-12-16
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Stone Extraction Baskets (K230598)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2023-09-12
SpyGlass Discover Retrieval Basket (K203322)Boston Scientific Corporation2021-05-26
Disposable Stone Extraction basket (K201509)Hangzhou AGS MedTech Co., Ltd.2020-12-16
Wilson-Cook Mini Basket (K182381)Wilson-Cook Medical, Inc.2018-10-30
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 (K171969)Wilson-Cook Medical, Inc.2018-03-28
Nathanson Transcystic Bile Duct Stone Exploration Pack (K171915)Cook Incorporated2018-03-01
Strange Bile Duct Stone Exploration Set (K173687)Cook Incorporated2017-12-15
Wittich Nitinol Stone Basket (K170898)Cook Incorporated2017-12-12

Recalls involving this device

No recalls on record reference this clearance.

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