Neurology · 510(k) · 2023
ENT EM
Brainlab AG. Cleared by FDA on 27 April 2023 under submission K223734, product code PGW (ear, nose, and throat stereotaxic instrument). What FDA's record says, in FDA's words.
Device record · K223734
- Device. ENT EMDEVICE
- Company. Brainlab AG (DE)COMPANY
- Decision. 27 April 2023, 510(k), substantially equivalent (traditional review); received 13 December 2022DECISION
- Panel. NeurologyPANEL
- Product code. PGW, Ear, Nose, And Throat Stereotaxic InstrumentCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
ENT EM is intended as an image-guided planning and navigation system to enable ENT procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as: * Intranasal structures and Paranasal Sinus Surgery o Functional endoscopic sinus surgery (FESS) o Intranasal structures and paranasal sinus surgery, including revision and distorted anatomy * Anterior skull base procedures
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, MRI, radiographs (X-ray), ultrasound, endoscopy
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,756 reports filed against devices carrying product code PGW. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 September 2026 · Malfunction · StealthStation FlexENT · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01381
25 September 2026 · Malfunction · SPINPLUS NAV 6x16mm 3 Guide · ACCLARENT, INC. · report 3003418325-2026-00042
It was reported that initially the SPINPLUS NAV 6x16mm 3 Guide (b)(6) "was tracking accurately until midway through the case it stopped being accurate." Inaccuracy was reportedly determined by "trying to get into frontal and showed the balloon in the brain. Inaccuracy was observed posterior. It was "off by 5 mm or more and then stopped tracking altogether". Staff opened a new SPINPLUS which was accurate from then on. There was no patient injury or delay in surgery.
24 September 2026 · Malfunction · StealthStation FlexENT · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01373
18 September 2026 · Malfunction · TruDi Navigation System · ACCLARENT, INC. · report 3003418325-2026-00039
It was reported that during Sinus Functional Endoscopic Sinus Surgery (FESS) the surgeon was not willing to proceed with use of image guidance/TruDi Navigation System (FG-2000-00) due to accuracy issues following registration; image did not align with anatomy after multiple registrations. Patient was re-registered (three 3) times and was reportedly still inaccurate near right and left orbits . The "surgeon then grabbed MDT machine and TruDi machine was not used for procedure". It was reported […]
14 September 2026 · Malfunction · Precision pointer Electromagnetic · Stryker Leibinger Freiburg · report 0008010177-2026-00167
It was reported that the Precision Pointer broke into half at first use when trying to perform the patient registration. No adverse consequences were reported with this event.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PGW, in Neurology, from Brainlab AG, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.