Devices · Brainlab AG

ENT EM

Brainlab AG is listed for ENT EM (K223734). The FDA list gives April 27, 2023 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PGW as “Ear, Nose, And Throat Stereotaxic Instrument”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K223734

Official FDA database record

Date of final decision

April 27, 2023

Company on the FDA list

Brainlab AG

Lead panel

Neurology

Primary product code

PGW

openFDA device name for the code

Ear, Nose, And Throat Stereotaxic Instrument

Device class

2

Regulation number

882.4560

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary