A LITHOTRIPTER-COMPATIBLE BASKET— 510(k) K964937

Name: FDA 510(k) clearance K964937
Creator: U.S. Food and Drug Administration
Published: 1997-01-24

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K964937 for A LITHOTRIPTER-COMPATIBLE BASKET, Substantially Equivalent on 1997-01-24. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LQC
Device class: Class 2
Regulation: 21 CFR 876.4500
Advisory panel: Gastroenterology, Urology
Date received: 1996-12-10
Decision date: 1997-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQC

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K040447 — TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 10882004-03-12
K011178 — WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR2001-05-04
K942544 — GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS1994-11-22
K943191 — MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR1994-08-29
K905552 — LAPAROLITH1991-12-17

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Adverse events under product code LQC

product code LQC

Death: 7
Injury: 247
Malfunction: 956
Total: 1,210

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.