HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX— 510(k) K853731

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K853731 for HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX, Substantially Equivalent on 1985-10-18. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1985-09-06
Decision date: 1985-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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.