510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K934261Substantially Equivalent

Erbokryo Ca Cryosurgical System

ERBE Elektromedizin GmbH, Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934261 is the FDA 510(k) clearance record for ERBOKRYO CA CRYOSURGICAL SYSTEM, a class II device, cleared for Erbe Elektromedizin GmbH on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 16 510(k) clearances for Erbe Elektromedizin GmbH, from to . As of , FDA records show no recalls naming K934261.

Clearance record

Decision date
Received
(238 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Erbe Elektromedizin GmbH 728 Laurinda Ln., Orange CA
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