HP-ONE— 510(k) K012411

Substantially Equivalent

Gi Supply

FDA 510(k) clearance K012411 for HP-ONE, Substantially Equivalent on 2001-09-25. Applicant: Gi Supply.

Clearance details

Applicant: Gi Supply
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2001-07-30
Decision date: 2001-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

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.