Identity
- Trade Name
- ACCLARENT NAVWIRE FDA UDI
- Generic Name
- Paranasal sinus guidewire FDA UDI
- Device Name
- ACCLARENT NAVWIRE SINUS NAVIGATION GUIDEWIRE FDA UDI
- Model / Reference
- GW35150NZ FDA UDI
- Description
- ACCLARENT NAVWIRE SINUS NAVIGATION GUIDEWIRE FDA UDI
Identifiers
- Catalog Number
- GW35150NZ FDA UDI
- Primary DI / UDI-DI
- 10705031237087 FDA UDI
- 510(k) Number
- K161697 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- Paranasal sinus guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Paranasal sinus guidewire
Acclarent Navwire by Acclarent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Paranasal sinus guidewire.
- MicroFrance® — Integra Microfrance · Class I
- TruDi NAVWIRE — ACCLARENT, INC. · Class II
- TruDi NAVWIRE — ACCLARENT, INC. · Class II
- ACCLARENT NAVWIRE — ACCLARENT, INC. · Class II
Cleared under the same submission
K161697 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Acclarent, Inc.
Sources (1)
- FDA UDI 08a494cb-ad33-4f91-b551-3b5a49114adb 37 fields · synced May 30, 2026