Smoke Evacuator Tubing

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: Smoke Evacuator Tubing FDA UDI
Generic Name: Surgical plume evacuation system tube FDA UDI
Model / Reference: 6084 FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937000054 FDA UDI
510(k) Number: K910377 FDA UDI
FDA Product Code: GCX FDA UDI
GMDN Term: Surgical plume evacuation system tube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6740 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: Lumen/Inner Diameter — 0.375 Inch FDA UDI
Outer Diameter — 0.5 Inch FDA UDI

Category: Surgical plume evacuation system tube

Smoke Evacuator Tubing by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical plume evacuation system tube.

Valleylab — Covidien LP · Class II
BCL Accessories Kit — CairnSurgical Inc · Class IIb
Surgimedics® — COASTAL LIFE TECHNOLOGIES, INC. · Class I
SUSI® — Aesculap AG · Class IIa
Gynex — GYNEX CORPORATION · Class I
Buffalo Filter — Conmed Corporation · Class II
Smoke Tubing — I.C. Medical, Inc. · Class II
STERILE SURGICAL SCISSORS — Anhui Medfaith Medical Devices Co., Ltd. · Class I

Cleared under the same submission

K910377 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: CooperSurgical, Inc.

Sources (1)

FDA UDI fbaa8ad5-e879-45ed-8650-c2a88dba5e26 34 fields · synced Jun 9, 2026