510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953542Substantially Equivalent for Some Indications

Coldgel

Prism Technologies, Inc., Washington DC / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K953542 is the FDA 510(k) clearance record for COLDGEL, a class I device, cleared for Prism Technologies, Inc. on under FDA product code IMD (Pack, Hot Or Cold, Disposable). FDA records list 5 510(k) clearances for Prism Technologies, Inc., from to . As of , FDA records show no recalls naming K953542.

Clearance record

Decision date
Received
(94 days to decision)
Product code
IMD Pack, Hot Or Cold, Disposable
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Applicant
Prism Technologies, Inc. 555 Thirteenth St. NW, Washington DC
Third party review
No

Clearances, product code IMD

Trailing 12 months

FDA records hold no clearances under product code IMD in the trailing twelve months.

FDA records show no clearances under product code IMD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260