510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K102802Substantially Equivalent

Integra Electrode Tunneling Needle

Integra LifeSciences Corporation, Planisboro NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102802 is the FDA 510(k) clearance record for INTEGRA ELECTRODE TUNNELING NEEDLE, a class II device, cleared for Integra LifeSciences Corporation on under FDA product code GYC (Electrode, Cortical). FDA records list 94 510(k) clearances for Integra LifeSciences Corporation, from to . As of , FDA records show no recalls naming K102802.

Clearance record

Decision date
Received
(57 days to decision)
Product code
GYC Electrode, Cortical
Regulation
21 CFR 882.1310
Device class
Class II
Review panel
Neurology
Applicant
Integra LifeSciences Corporation 311 Enterprise Dr., Planisboro NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GYC

Trailing 12 months

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

FDA records show no clearances under product code GYC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260