RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder— 510(k) K173279

Substantially Equivalent

Myco Medical Supplies, Inc.

FDA 510(k) clearance K173279 for RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder, Substantially Equivalent on 2018-05-14. Applicant: Myco Medical Supplies, Inc..

Clearance details

Applicant: Myco Medical Supplies, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2017-10-13
Decision date: 2018-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apex, NC, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.