Chrysalis Intelligence · Product Codes · PGW

PGW · Unclassified

16 clearances · 8 unique sponsors

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Device class
—
Regulation —
Total clearances
16
2020-01-30 → 2026-06-02
Last 12 months
2
Unique sponsors
8
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Acclarent, Inc. 4 0 2023-07-21
Fiagon GmbH 3 1 2026-06-02
Stryker Corporation 2 0 2022-07-12
Stryker Ent 2 0 2020-02-21
Medtronic Navigation, Inc. 2 1 2026-03-16
Biosense Webster 1 0 2020-01-30
Brainlab AG 1 0 2023-04-27
Claronav 1 0 2025-06-20
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
61795 CPT — Medium Stereotactic procedure; computer-assisted navigation; covers ENT stereotaxic guidance
69400 CPT — Low Eustachian tube catheterization; non-specific ENT surgical instrument code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-02 K261540 Fiagon GmbH Cube 4D Navigation System, VirtuEye Pro
2026-03-16 K253395 Medtronic Navigation, Inc. Stealth AXiS™ ENT clinical application
2025-06-20 K243053 Claronav Navient Image Guided Navigation System (ENT) (955-NC-NC)
2023-07-21 K231862 Acclarent, Inc. TruDi® Navigation System V3 (FG-2000-00)
2023-04-27 K223734 Brainlab AG ENT EM
2022-07-20 K221037 Acclarent, Inc. TruDi Shaver Blade
2022-07-12 K221098 Stryker Corporation Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
2021-07-19 K211291 Fiagon GmbH Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
2020-10-09 K202609 Stryker Corporation Instrument Clamps Electromagnetic
2020-08-12 K201174 Acclarent, Inc. TruDi Curette
2020-06-26 K200723 Medtronic Navigation, Inc. StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
2020-03-23 K193453 Acclarent, Inc. TruDi Probe
2020-03-10 K200041 Fiagon GmbH FlexPointer 1.5 Single Use, FlexTube 3 Single Use
2020-02-21 K193118 Stryker Ent TGS Guidewire and updated Scopis Software
2020-02-14 K193502 Stryker Ent TGS Universal Headrest with Mounting Arm
2020-01-30 K192397 Biosense Webster TruDi Navigation System
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence