510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110609Substantially Equivalent

Epiducer Lead Delivery System

Abbott Medical, Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K110609 is the FDA 510(k) clearance record for EPIDUCER LEAD DELIVERY SYSTEM, a class II device, cleared for St Jude Medical on under FDA product code LHG (Electrode, Spinal Epidural). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K110609.

Clearance record

Decision date
Received
(113 days to decision)
Product code
LHG Electrode, Spinal Epidural
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
St Jude Medical 6901 Preston Rd., Plano TX
510(k) summary
Statement
Third party review
No

Clearances, product code LHG

Trailing 12 months

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

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