510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K062339Substantially Equivalent

Dermotherap Gun

Dermoequipos S.r.l., M.P. Misgav, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K062339 is the FDA 510(k) clearance record for DERMOTHERAP GUN, a class II device, cleared for Dermoequipos S.R.L. on under FDA product code KZH (Introducer, Syringe Needle). FDA records list one 510(k) clearance for Dermoequipos S.R.L. As of , FDA records show no recalls naming K062339.

Clearance record

Decision date
Received
(179 days to decision)
Product code
KZH Introducer, Syringe Needle
Regulation
21 CFR 880.6920
Device class
Class II
Review panel
General Hospital
Applicant
Dermoequipos S.R.L. Mitzpe Aviv Industrial Park 13, M.P. Misgav, IL
510(k) summary
Statement
Third party review
No

Clearances, product code KZH

Trailing 12 months

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

FDA records show no clearances under product code KZH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZH, 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