Atlas FDA

LQC

11 FDA 510(k) clearances · Product code

72 daysmedian time to decision
209 days90th percentile
11clearances measured

FDA profile

Official device name
Lithotriptor, Biliary Mechanical
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 112 · 2022: 245 · 2023: 224 · 2024: 301 · 2025: 127 · 2026: 124
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 (K040447)Boston Scientific Corp2004-03-12
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR (K011178)Wilson-Cook Medical, Inc.2001-05-04
A LITHOTRIPTER-COMPATIBLE BASKET (K964937)Boston Scientific Corp1997-01-24
GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS (K942544)Medi-Globe Corp.1994-11-22
MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR (K943191)Boston Scientific Corp1994-08-29
LAPAROLITH (K905552)Baxter Healthcare Corp1991-12-17
SPOON FORCEPS, 11MM (K911364)Northgate Technologies, Inc.1991-10-23
LAPAROSCOPIC BASKET FLEXIBLE AND RIGID (K911477)United States Endoscopy Group, Inc.1991-08-14
BML SERIES (K903529)Olympus Corp.1991-01-23
SOEHENDRA LITHOTRIPSY SET (K902170)Wilson-Cook Medical, Inc.1990-07-25
ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER (K860863)George Percy Mcgown1986-05-15

Track LQC automatically

Every clearance here is in the API, with alerts when new ones post.