510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K912529Substantially Equivalent

Ergomed

Kryoderm USA, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912529 is the FDA 510(k) clearance record for ERGOMED, a class II device, cleared for Kryoderm USA, Inc. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list one 510(k) clearance for Kryoderm USA, Inc. As of , FDA records show no recalls naming K912529.

Clearance record

Decision date
Received
(1,054 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kryoderm USA, Inc. 2189 Cleveland St., Clearwater FL
510(k) summary
Statement
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260