PROSAFE SAFETY SYRINGE— 510(k) K012726

Substantially Equivalent

Hou-Se Medical, Inc.

FDA 510(k) clearance K012726 for PROSAFE SAFETY SYRINGE, Substantially Equivalent on 2001-10-18. Applicant: Hou-Se Medical, Inc..

Clearance details

Applicant: Hou-Se Medical, Inc.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2001-08-15
Decision date: 2001-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

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Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.