Lithotriptor, Biliary Mechanical
The Biliary Mechanical Lithotriptor is a device used endoscopically to crush or fragment gallstones or bile duct stones through mechanical force, facilitating their removal or natural passage through the biliary tract. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LQC, regulated under 21 CFR 876.4500, within the Gastroenterology and Urology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LQC
- Device Class
- FDA class 2
- Regulation Number
- 876.4500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040447 | TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 | Mar 12, 2004 | Substantially Equivalent | Boston Scientific Corp |
| K011178 | WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR | May 04, 2001 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K964937 | A LITHOTRIPTER-COMPATIBLE BASKET | Jan 24, 1997 | Substantially Equivalent | Boston Scientific Corp |
| K942544 | GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS | Nov 22, 1994 | Substantially Equivalent | Medi-Globe Corp. |
| K943191 | MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR | Aug 29, 1994 | Substantially Equivalent | Boston Scientific Corp |
| K905552 | LAPAROLITH | Dec 17, 1991 | Substantially Equivalent | Baxter Healthcare Corp |
| K911364 | SPOON FORCEPS, 11MM | Oct 23, 1991 | Substantially Equivalent | Northgate Technologies, Inc. |
| K911477 | LAPAROSCOPIC BASKET FLEXIBLE AND RIGID | Aug 14, 1991 | Substantially Equivalent | United States Endoscopy Group, Inc. |
| K903529 | BML SERIES | Jan 23, 1991 | Substantially Equivalent | Olympus Corp. |
| K902170 | SOEHENDRA LITHOTRIPSY SET | Jul 25, 1990 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K860863 | ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER | May 15, 1986 | Substantially Equivalent | George Percy Mcgown |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.