510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K014165Substantially Equivalent

Stimulus - Dissection Instruments

Medtronic Xomed, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014165 is the FDA 510(k) clearance record for STIMULUS - DISSECTION INSTRUMENTS, a class II device, cleared for Medtronic Xomed, Inc. on under FDA product code ETN (Stimulator, Nerve). FDA records list 46 510(k) clearances for Medtronic Xomed, Inc., from to . As of , FDA records show no recalls naming K014165.

Clearance record

Decision date
Received
(34 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Medtronic Xomed, Inc. 6743 Southpoint Dr. N., Jacksonville FL
510(k) summary
Summary
Third party review
No

Clearances, product code ETN

Trailing 12 months
2 clearances under product code ETN in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260