510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882405Substantially Equivalent

Hypodermic Needle Sheath Holder

Ansr Ent., Inc., Franktown CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882405 is the FDA 510(k) clearance record for HYPODERMIC NEEDLE SHEATH HOLDER, a class II device, cleared for Ansr Ent., Inc. on under FDA product code FMJ (Manometer, Spinal-Fluid). FDA records list one 510(k) clearance for Ansr Ent., Inc. As of , FDA records show no recalls naming K882405.

Clearance record

Decision date
Received
(19 days to decision)
Product code
FMJ Manometer, Spinal-Fluid
Regulation
21 CFR 880.2500
Device class
Class II
Review panel
General Hospital
Applicant
Ansr Ent., Inc. 1775 S. Tomichi, Franktown CO
Third party review
No

Clearances, product code FMJ

Trailing 12 months

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

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