ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)— 510(k) K011369

Substantially Equivalent

Safety Syringes, Inc.

FDA 510(k) clearance K011369 for ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY), Substantially Equivalent on 2001-05-29. Applicant: Safety Syringes, Inc..

Clearance details

Applicant: Safety Syringes, Inc.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2001-05-04
Decision date: 2001-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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.