510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080877Substantially Equivalent

1Ml Unitract Insulin Syringe 27G*1/2 , 1Ml Unitract Syringe 29G*1/2

Unilife Medical Solutions Limited, Sydney, Nsw, AU / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080877 is the FDA 510(k) clearance record for 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2, a class II device, cleared for Unilife Medical Solutions Limited on under FDA product code MEG (Syringe, Antistick). FDA records list 3 510(k) clearances for Unilife Medical Solutions Limited, from to . As of , FDA records show no recalls naming K080877.

Clearance record

Decision date
Received
(204 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Unilife Medical Solutions Limited Level 5, 35 Clarence St., Sydney, Nsw, AU
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