510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253395Substantially Equivalent

Stealth AXiS™ ENT clinical application

Medtronic Navigation, Inc, Lafayette CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253395 is the FDA 510(k) clearance record for Stealth AXiS™ ENT clinical application, a class II device, cleared for Medtronic Navigation, Inc. on under FDA product code PGW (Ear, Nose, And Throat Stereotaxic Instrument). FDA's definition for product code PGW reads: "Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT...". FDA records list 85 510(k) clearances for Medtronic Navigation, Inc., from to . As of , FDA records show no recalls naming K253395.

Clearance record

Decision date
Received
(167 days to decision)
Product code
PGW Ear, Nose, And Throat Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Navigation, Inc. 200 Medtronic Dr., Lafayette CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGW

Trailing 12 months
3 clearances under product code PGW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PGW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260