510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790104Substantially Equivalent

Pistormatic

Zelby, Burstein, Hartman & Burstein, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790104 is the FDA 510(k) clearance record for PISTORMATIC, a class II device, cleared for Zelby, Burstein, Hartman & Burstein on under FDA product code KZH (Introducer, Syringe Needle). FDA records list one 510(k) clearance for Zelby, Burstein, Hartman & Burstein. As of , FDA records show no recalls naming K790104.

Clearance record

Decision date
Received
(118 days to decision)
Product code
KZH Introducer, Syringe Needle
Regulation
21 CFR 880.6920
Device class
Class II
Review panel
General Hospital
Applicant
Zelby, Burstein, Hartman & Burstein 803 N. Front St. Suite 3, Mchenry IL
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