LAPAROLITH— 510(k) K905552

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K905552 for LAPAROLITH, Substantially Equivalent on 1991-12-17. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LQC
Advisory panel: Gastroenterology, Urology
Date received: 1990-12-11
Decision date: 1991-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.