510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851089Substantially Equivalent

Monoject Sterile 12Cc Syringes, W/wo Needles

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

K851089 is the FDA 510(k) clearance record for MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES, a class II device, cleared for Sherwood Medical Co. on under FDA product code FMF (Syringe, Piston). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K851089.

Clearance record

Decision date
Received
(25 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Sherwood Medical Co. 1915 Olive St., St. Louis MO
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260