Arthroport

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Arthroport FDA UDI
Generic Name: Laparoscopic access cannula, reusable FDA UDI
Device Name: Cannula System FDA UDI
Model / Reference: 160204 FDA UDI
Description: Cannula System FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521180635 FDA UDI
510(k) Number: K963115 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Laparoscopic access cannula, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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 — 70 Millimeter FDA UDI
Outer Diameter — 6 Millimeter FDA UDI

Category: Laparoscopic access cannula, reusable

Arthroport by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic access cannula, reusable.

Surgical Direct — SURGICAL DIRECT, INC. · Class II
Single-Site — Intuitive Surgical, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
ELMED — ELMED INCORPORATED · Class II
Gimmi — Gimmi GmbH · Class II
BLUEENDO — TROKAMED GmbH · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
AESCULAP — AESCULAP, INC. · Class II

Cleared under the same submission

K963115 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: Covidien LP

Sources (1)

FDA UDI a274d919-4fef-4bc0-9554-7d4614126feb 36 fields · synced May 31, 2026