510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964027Substantially Equivalent

Stp System-Pva with Mercury

Sage Products LLC, Crystal Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964027 is the FDA 510(k) clearance record for STP SYSTEM-PVA WITH MERCURY, a class I device, cleared for Sage Products, Inc. on under FDA product code LIO (Device, Specimen Collection). FDA records list 31 510(k) clearances for Sage Products, Inc., from to . As of , FDA records show no recalls naming K964027.

Clearance record

Decision date
Received
(25 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Sage Products, Inc. 815 Tek Dr., Crystal Lake IL
510(k) summary
Summary
Third party review
No

Clearances, product code LIO

Trailing 12 months

FDA records hold no clearances under product code LIO in the trailing twelve months.

FDA records show no clearances under product code LIO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIO, 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