INSTANT COLDGEL— 510(k) K953541

Name: FDA 510(k) clearance K953541
Creator: U.S. Food and Drug Administration
Published: 1995-10-05

Substantially Equivalent

Prism Technologies, Inc.

FDA 510(k) clearance K953541 for INSTANT COLDGEL, Substantially Equivalent on 1995-10-05. Applicant: Prism Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Prism Technologies, Inc.
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 1995-07-28
Decision date: 1995-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K980212 — MITYVAC1998-07-09
K953542 — COLDGEL1995-10-30
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Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.