TRANCOJECT DISPOSABLE SYRINGES— 510(k) K832605

Substantially Equivalent

Huborga, Inc.

FDA 510(k) clearance K832605 for TRANCOJECT DISPOSABLE SYRINGES, Substantially Equivalent on 1983-11-14. Applicant: Huborga, Inc..

Clearance details

Applicant: Huborga, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1983-08-03
Decision date: 1983-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.