Panels › Gastroenterology, Urology › Product code LQR · Class 2
Dislodger, Stone, Biliary
Regulation 876.5010
1510(k)s in 12 months (38 all time)
2recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in LQR
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 6 | 9 |
| Cook Incorporated | 6 | 2 |
| Olympus Medical Systems Corp. | 3 | 0 |
| Wilson-Cook Medical, Inc. | 3 | 0 |
| Ideal Medical, Inc. | 2 | 0 |
| Wiltek Medical, Inc. | 2 | 0 |
| Annex Medical, Inc. | 1 | 0 |
| Cape Tech Medical Products | 1 | 0 |
| Hangzhou AGS MedTech Co., Ltd. | 1 | 0 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250;
Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251. Open, Classified |
LQR | K173009 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108 Open, Classified |
LQR | K173687 |
| Mar 11, 2009 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3515.
The device is used in diagnostic or th Terminated |
LQR | K946358 |
| Mar 11, 2009 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3513.
The device is used in diagnostic or th Terminated |
LQR | K946358 |
| Mar 11, 2009 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511.
The device is used in diagnostic or t Terminated |
LQR | K946358 |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521. Terminated |
LQR | K946358 |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535190; catalog number 3519. Terminated |
LQR | K946358 |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517. Terminated |
LQR | K946358 |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog number 3515. Terminated |
LQR | K946358 |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513. Terminated |
LQR | K946358 |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511. Terminated |
LQR | K946358 |
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