TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088— 510(k) K040447

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K040447 for TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088, Substantially Equivalent on 2004-03-12. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LQC
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-20
Decision date: 2004-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

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.