FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K171969
·
Decision Mar 28, 2018
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
37
Applicant Total
125
Review Days
271
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 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
- K Number
- K171969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wilson-Cook Medical, Inc.
- Date Received
- June 30, 2017
- Decision Date
- March 28, 2018
- Product Code
- LQR
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LQR | Dislodger, Stone, Biliary | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQR), ordered by most recent decision date.
Disposable Stone Extraction Basket
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Extraction Basket
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single-use Extraction Baskets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stone Extraction Baskets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SpyGlass Discover Retrieval Basket
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Wilson-Cook Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | Jun 2, 2026 | Substantially Equivalent |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Jan 17, 2025 | Substantially Equivalent |
| K213356 | Entuit PEG, Entuit PEGJ | Jan 20, 2022 | Unknown |
| K212323 | Instinct Plus Endoscopic Clipping Device | Aug 25, 2021 | Substantially Equivalent |
| K201322 | Entuit Nasal Jejunal Feeding Tube | Jun 17, 2020 | Unknown |
| K200972 | Hemospray Endoscopic Hemostat | Jun 10, 2020 | Substantially Equivalent |
| K200247 | Fusion Quattro Extraction Balloon | Feb 27, 2020 | Substantially Equivalent |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Jan 30, 2020 | Substantially Equivalent |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | Dec 13, 2019 | Substantially Equivalent |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Nov 14, 2019 | Substantially Equivalent |