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

Ear, Nose, And Throat Stereotaxic Instrument

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

PGW is the FDA product code for Ear, Nose, And Throat Stereotaxic Instrument, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code 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 surgery can be identified relative to a CT- or MR-based model or digitized landmarks...". As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
PGW
Device name
Ear, Nose, And Throat Stereotaxic Instrument
FDA definition
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 surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
38
Ingested recalls
17

Clearances, product code PGW

By decision year
38 clearances under product code PGW with a decision year between 2014 and 2026, 2016 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code PGW by decision year
YearClearances
20144
20151
20169
20174
20182
20191
20208
20211
20222
20232
20251
20263

Applicants with the most clearances

Product code PGW
Applicants holding the most 510(k) clearances under product code PGW
ApplicantClearances
Fiagon GmbH11
Acclarent Inc8
Medtronic Navigation, Inc6
Biosense Webster Inc2
Scopis GmbH2
Stryker Corp.2
Stryker Ent2
Brainlab, Inc.1
ClaroNav Inc.1
Karl Storz Endoscopy-America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 39 companies shown, in name order