510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K031065Substantially Equivalent

Syringex Safety Syringe, Model 0322G1.5

Syringex Medical, Inc., Draper UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031065 is the FDA 510(k) clearance record for SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5, a class II device, cleared for Syringex Medical, Inc. on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Syringex Medical, Inc. As of , FDA records show no recalls naming K031065.

Clearance record

Decision date
Received
(81 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Syringex Medical, Inc. 2311 Bear Hills Ct., Draper UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEG

Trailing 12 months
2 clearances under product code MEG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260