510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941291Substantially Equivalent

Monoject Samplette Separator Tube

Sherwood Medical Co., St.Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941291 is the FDA 510(k) clearance record for MONOJECT SAMPLETTE SEPARATOR TUBE, a class I device, cleared for Sherwood Medical Co. on under FDA product code GIO (Tube, Collection, Capillary Blood). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K941291.

Clearance record

Decision date
Received
(224 days to decision)
Product code
GIO Tube, Collection, Capillary Blood
Regulation
21 CFR 864.6150
Device class
Class I
Review panel
Hematology
Applicant
Sherwood Medical Co. 1831 Olive St., St.Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code GIO

Trailing 12 months

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

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