AccessVu 60

FDA UDI

Class II (US FDA UDI)

by Intravu, Inc.

Identity

Trade Name: AccessVu 60 FDA UDI
Generic Name: Rigid optical arthroscope, single-use FDA UDI
Device Name: Disposable accessory kit to be used with IntraVu Scope 60. Kit contains 60mm cannula, 60mm trocar, cannula cap and stopcock. FDA UDI
Model / Reference: IV-ASY-1606 FDA UDI
Description: Disposable accessory kit to be used with IntraVu Scope 60. Kit contains 60mm cannula, 60mm trocar, cannula cap and stopcock. FDA UDI

Identifiers

Catalog Number: IV-ASY-1606 FDA UDI
Primary DI / UDI-DI: 00850023905017 FDA UDI
510(k) Number: K181982 FDA UDI
FDA Product Code: HRX FDA UDI
GCJ FDA UDI
GMDN Term: Rigid optical arthroscope, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
876.1500 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

FDA UDI

Dimensions & Sizes

Size: Length — 60 Millimeter FDA UDI

Category: Rigid optical arthroscope, single-use

AccessVu 60 by Intravu, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Rigid optical arthroscope, single-use.

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Summit Hi-Flow Cannula — Pristine Surgical · Class I

Cleared under the same submission

K181982 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: Intravu, Inc.

Sources (1)

FDA UDI d6bab687-d20b-48d9-a8ec-601e02abb9a4 38 fields · synced May 30, 2026