IXL DIABETES MANAGEMENT SYSTEM— 510(k) K031373

Substantially Equivalent

Insulet Corp.

FDA 510(k) clearance K031373 for IXL DIABETES MANAGEMENT SYSTEM, Substantially Equivalent on 2003-12-19. Applicant: Insulet Corp..

Clearance details

Applicant: Insulet Corp.
Product code: Code LZG
Advisory panel: General Hospital
Date received: 2003-04-30
Decision date: 2003-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

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Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.