PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES— 510(k) K002381

Substantially Equivalent

Pentaferte, S.R.L.

FDA 510(k) clearance K002381 for PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES, Substantially Equivalent on 2001-01-11. Applicant: Pentaferte, S.R.L..

Clearance details

Applicant: Pentaferte, S.R.L.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2000-08-04
Decision date: 2001-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campli (Teramo), IT

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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.