510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904380Unknown

Spinal Cord Access Epidural Introducer System

Custom Medical Concepts, Inc., Chelmsford MA / Traditional, Unknown
FDA source (opens on fda.gov)

K904380 is the FDA 510(k) clearance record for SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM, a class II device, cleared for Custom Medical Concepts, Inc. on under FDA product code MIA (Needle, Spinal, Short Term). FDA records list one 510(k) clearance for Custom Medical Concepts, Inc. As of , FDA records show no recalls naming K904380.

Clearance record

Decision date
Received
(925 days to decision)
Product code
MIA Needle, Spinal, Short Term
Regulation
21 CFR 868.5150
Device class
Class II
Review panel
Anesthesiology
Applicant
Custom Medical Concepts, Inc. 26 High St., Chelmsford MA
Third party review
No

Clearances, product code MIA

Trailing 12 months

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

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