510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K974726Substantially Equivalent

Subdural Drainage Catheter Kit, Subdural Catheter

Elekta Implants, SA, Coral Gables FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974726 is the FDA 510(k) clearance record for SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER, a class II device, cleared for Elekta Implants, SA on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 2 510(k) clearances for Elekta Implants, SA, from to . As of , FDA records show no recalls naming K974726.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Elekta Implants, SA 6011 Cellini St., Coral Gables FL
510(k) summary
Summary
Third party review
No

Clearances, product code JXG

Trailing 12 months
5 clearances under product code JXG in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
November 20252
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261