ULTRASAFE PASSIVE NEEDLE GUARD— 510(k) K122558

Substantially Equivalent

Safety Syringes, Inc.

FDA 510(k) clearance K122558 for ULTRASAFE PASSIVE NEEDLE GUARD, Substantially Equivalent on 2012-09-20. Applicant: Safety Syringes, Inc..

Clearance details

Applicant: Safety Syringes, Inc.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2012-08-22
Decision date: 2012-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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.