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Coblation

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Coblation FDA UDI
Generic Name
Universal foot-controlled electrosurgical diathermy system conducting unit, single-use FDA UDI
Device Name
TOPAZ ICW FDA UDI
Model / Reference
AC4040-01 FDA UDI
Description
TOPAZ ICW FDA UDI

Identifiers

Catalog Number
AC4040-01 FDA UDI
Primary DI / UDI-DI
00817470003109 FDA UDI
510(k) Number
K080282 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Universal foot-controlled electrosurgical diathermy system conducting unit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Universal foot-controlled electrosurgical diathermy system conducting unit, single-use

Coblation by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Universal foot-controlled electrosurgical diathermy system conducting unit, single-use.

Cleared under the same submission

K080282 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 30e71ec5-4fda-43b7-9002-77be70f07caa 36 fields · synced Jun 8, 2026