INSTASPOT— 510(k) K942504

Substantially Equivalent

Fidelity Medical, Inc.

FDA 510(k) clearance K942504 for INSTASPOT, Substantially Equivalent on 1995-05-05. Applicant: Fidelity Medical, Inc..

Clearance details

Applicant: Fidelity Medical, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1994-05-26
Decision date: 1995-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Florham Park, NJ, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.