510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K060928Substantially Equivalent

Cryoshape

Etgar Group H.M.Y.A., Ltd., Kfar-Saba, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060928 is the FDA 510(k) clearance record for CRYOSHAPE, a class II device, cleared for Etgar Group H.M.Y.A. , Ltd. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list one 510(k) clearance for Etgar Group H.M.Y.A. , Ltd. As of , FDA records show no recalls naming K060928.

Clearance record

Decision date
Received
(48 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Etgar Group H.M.Y.A. , Ltd. 37a Rothschild St., 44449, Kfar-Saba, IL
510(k) summary
Summary PDF
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