510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192397Substantially Equivalent

TruDi Navigation System

Biosense Webster Inc, Irvin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192397 is the FDA 510(k) clearance record for TruDi Navigation System, a class II device, cleared for Biosense Webster 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 76 510(k) clearances for Biosense Webster, from to . As of , FDA records show one recall naming K192397.

Clearance record

Decision date
Received
(149 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
Biosense Webster 33 Technology Dr., Irvin CA
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