510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K000387Substantially Equivalent

Terumo Needle with Locking Sheath

Terumo Medical Corp., Elkton MD / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K000387 is the FDA 510(k) clearance record for TERUMO NEEDLE WITH LOCKING SHEATH, a class II device, cleared for Terumo Medical Corp. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K000387.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
510(k) summary
Summary
Third party review
No

Clearances, product code FMI

Trailing 12 months
12 clearances under product code FMI in the twelve months to November 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260
November 20260