PGW
Acclarent ENT Navigation System
- Advisory panel
- Neurology
- Total cleared
- 36
Adverse events under product code PGW
product code PGW- Malfunction
- 1,199
- Total
- 1,199
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PGW
- K253395 — Stealth AXiS ENT clinical application
- K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC)
- K231862 — TruDi® Navigation System V3 (FG-2000-00)
- K223734 — ENT EM
- K221037 — TruDi Shaver Blade
- K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
- K211291 — Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
- K202609 — Instrument Clamps Electromagnetic
- K201174 — TruDi Curette
- K200723 — StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
- K193453 — TruDi Probe
- K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use
- K193118 — TGS Guidewire and updated Scopis Software
- K193502 — TGS Universal Headrest with Mounting Arm
- K192397 — TruDi Navigation System
- K190532 — TruDi NAV Wire
- K180948 — TruDi NAV Suction Instruments
- K173628 — Acclarent ENT Navigation System
- K171661 — Scopis Extended Instrument Set EM
- K170018 — StealthStationTM S8 ENT Software
- K163416 — Fiagon Navigation PointerTube Straight and PointerTube Keat
- K161491 — Scopis Hybrid Navigation System EM
- K162176 — Fiagon Navigation System
- K161697 — Acclarent NavWire Sinus Navigation Guidewire
- K161701 — CARTO ENT System
- K161555 — KARL STORZ NAV1 Electromagnetic Navigation System
- K161940 — Guidewire 0.6 Single Use
- K153555 — EM ENT Navigated Suctions
- K160479 — PointerShell Universal, PointerShell LS
- K160369 — GuideWire
- K153247 — Fusion Compact Navigation System
- K150473 — FlexPointer 1.5 mm
- K141456 — THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
- K141551 — PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
- K133573 — FIAGON NAVIGATION SYSTEM
- K133665 — MALLEABLE SUCTION INSTRUMENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.