Acclarent Pivot

FDA UDI

Class II (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name: ACCLARENT PIVOT FDA UDI
Generic Name: Eustachian catheter, single-use FDA UDI
Device Name: ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK FDA UDI
Model / Reference: PVT0616NZ FDA UDI
Description: ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK FDA UDI

Identifiers

Catalog Number: PVT0616NZ FDA UDI
Primary DI / UDI-DI: 20705031465609 FDA UDI
510(k) Number: K201115 FDA UDI
FDA Product Code: PGW FDA UDI
LRC FDA UDI
PNZ FDA UDI
GMDN Term: Eustachian catheter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
874.4420 FDA UDI
874.4180 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: Eustachian catheter, single-use

Acclarent Pivot by Acclarent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eustachian catheter, single-use.

XprESS Ultra — Stryker Corp. · Class I
TubaVent® short wide — Spiggle & Theis Medizintechnik GmbH · Class II
NuVent — MEDTRONIC XOMED, INC. · Class II
Audion — Stryker Corp. · Class II
TubaVent® short — Spiggle & Theis Medizintechnik GmbH · Class II
XprESS LoProfile — Stryker Corp. · Class I
XprESS Ultra — Stryker Corp. · Class I
XprESS LoProfile — Stryker Corp. · Class I

Cleared under the same submission

K201115 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 eb04089f-83b1-4194-a46c-21692f4e5fb9 37 fields · synced May 30, 2026