510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112214Substantially Equivalent

Octrodex(tm), Quattrodex(tm), Introdex(tm), Epidural Needle, Stylets

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

K112214 is the FDA 510(k) clearance record for OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS, a class II device, cleared for St. Jude Medical Neuromodulation on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list 2 510(k) clearances for St. Jude Medical Neuromodulation, from to . As of , FDA records show no recalls naming K112214.

Clearance record

Decision date
Received
(107 days to decision)
Product code
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
St. Jude Medical Neuromodulation 6901 Preston Rd., Plano TX
510(k) summary
Statement
Third party review
No

Clearances, product code GZB

Trailing 12 months

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

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