DISPOSABLE PLASTIC SYRINGES— 510(k) K851523

Substantially Equivalent

Transcoject GmbH & Co. KG

FDA 510(k) clearance K851523 for DISPOSABLE PLASTIC SYRINGES, Substantially Equivalent on 1985-07-24. Applicant: Transcoject GmbH & Co. KG.

Clearance details

Applicant: Transcoject GmbH & Co. KG
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1985-04-16
Decision date: 1985-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neumuenster, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.