LQC · Lithotriptor, Biliary Mechanical
Gastroenterology, Urology · 21 CFR 876.4500 · Class 2
Overview
| Product Code | LQC |
|---|---|
| Device Name | Lithotriptor, Biliary Mechanical |
| Regulation | 21 CFR 876.4500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.
Classification Rationale
Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040447 | TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 | Boston Scientific Corp | Mar 12, 2004 | SESE |
| K011178 | WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR | Wilson-Cook Medical, Inc. | May 4, 2001 | SESE |
| K964937 | A LITHOTRIPTER-COMPATIBLE BASKET | Boston Scientific Corp | Jan 24, 1997 | SESE |
| K942544 | GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS | Medi-Globe Corp. | Nov 22, 1994 | SESE |
| K943191 | MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR | Boston Scientific Corp | Aug 29, 1994 | SESE |
| K905552 | LAPAROLITH | Baxter Healthcare Corp | Dec 17, 1991 | SESE |
| K911364 | SPOON FORCEPS, 11MM | Northgate Technologies, Inc. | Oct 23, 1991 | SESE |
| K911477 | LAPAROSCOPIC BASKET FLEXIBLE AND RIGID | United States Endoscopy Group, Inc. | Aug 14, 1991 | SESE |
| K903529 | BML SERIES | Olympus Corp. | Jan 23, 1991 | SESE |
| K902170 | SOEHENDRA LITHOTRIPSY SET | Wilson-Cook Medical, Inc. | Jul 25, 1990 | SESE |
| K860863 | ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER | George Percy Mcgown | May 15, 1986 | SESE |
Top Applicants
- Boston Scientific Corp — 3 clearances
- Wilson-Cook Medical, Inc. — 2 clearances
- United States Endoscopy Group, Inc. — 1 clearance
- Olympus Corp. — 1 clearance
- Northgate Technologies, Inc. — 1 clearance
