510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K012726Substantially Equivalent

Prosafe Safety Syringe

Hou-Se Medical, Inc., Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012726 is the FDA 510(k) clearance record for PROSAFE SAFETY SYRINGE, a class II device, cleared for Hou-Se Medical, Inc. on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Hou-Se Medical, Inc. As of , FDA records show no recalls naming K012726.

Clearance record

Decision date
Received
(64 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Hou-Se Medical, Inc. P.O. Box 630374, Irving TX
510(k) summary
Summary
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