COLDGEL— 510(k) K953542

Name: FDA 510(k) clearance K953542
Creator: U.S. Food and Drug Administration
Published: 1995-10-30

Substantially Equivalent for Some Indications

Prism Technologies, Inc.

FDA 510(k) clearance K953542 for COLDGEL, Substantially Equivalent for Some Indications on 1995-10-30. 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: 1995-10-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IMD

view all

K221653 — InfaTherm Disposable Infant Warming Mattress2022-10-06
K163295 — Infant Transport Mattress Warmer with Disc2017-07-24
K112547 — NEO NEST2012-03-06
K082087 — EYEFEEL OPHTHALMIC WARMER2008-09-11
K071710 — BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)2007-08-14

More clearances from Prism Technologies, Inc.

view all

K980212 — MITYVAC1998-07-09
K953541 — INSTANT COLDGEL1995-10-05
K934631 — TRANSWARMER1994-02-03
K912715 — INSTANT WARM GEL PACK1991-10-02

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.