Relieva Spinplus Nav

FDA UDI

Class I (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name: RELIEVA SPINPLUS NAV FDA UDI
Generic Name: Nasal/paranasal balloon catheter FDA UDI
Device Name: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT FDA UDI
Model / Reference: RSP0616MFSN FDA UDI
Description: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT FDA UDI

Identifiers

Catalog Number: RSP0616MFSN FDA UDI
Primary DI / UDI-DI: 10705031241015 FDA UDI
510(k) Number: K171687 FDA UDI
FDA Product Code: LRC FDA UDI
PGW FDA UDI
GMDN Term: Nasal/paranasal balloon catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nasal/paranasal balloon catheter

Relieva Spinplus Nav by Acclarent, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nasal/paranasal balloon catheter.

XprESS Ultra — Stryker Corp. · Class I
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NuVent ™ — MEDTRONIC XOMED, INC. · Class I
NuVent ™ — MEDTRONIC XOMED, INC. · Class I
VenSure Balloon Dilation System — Fiagon GmbH · Class I
VenSure Nav Balloon Dilation System — Fiagon GmbH · Class I
BB 8 Sinus Dilation Kit — Excelent, Inc. · Class I
NuVent ™ — MEDTRONIC XOMED, INC. · Class I

Cleared under the same submission

K171687 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 I	Pending data

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Manufacturer

Manufacturer: Acclarent, Inc.

Sources (1)

FDA UDI 14b54b4a-21bd-4a45-b9ef-87c843264ba0 37 fields · synced Jun 6, 2026