510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003555Substantially Equivalent

Solo-Safe Safety Syringe, Size-3Cc

Spectrum Biotech, Inc., N.Vancouver, British Columbia, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003555 is the FDA 510(k) clearance record for SOLO-SAFE SAFETY SYRINGE, SIZE-3CC, a class II device, cleared for Spectrum Biotech, Inc. on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Spectrum Biotech, Inc. As of , FDA records show no recalls naming K003555.

Clearance record

Decision date
Received
(285 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Spectrum Biotech, Inc. 821 E. 17th St., N.Vancouver, British Columbia, CA
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