← Back to catalogue

Coblation

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
COBLATION FDA UDI
Generic Name
Electrosurgical system generator FDA UDI
Device Name
COBLATOR II SYSTEM (240 V) FDA UDI
Model / Reference
EC8001-01 FDA UDI
Description
COBLATOR II SYSTEM (240 V) FDA UDI

Identifiers

Catalog Number
EC8001-01 FDA UDI
Primary DI / UDI-DI
00817470002164 FDA UDI
510(k) Number
K030108 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrosurgical system generator 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrosurgical system generator

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

Similar devices

Also classified as Electrosurgical system generator.

Cleared under the same submission

K030108 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI f95ba37e-fb5d-496a-a1c9-93340ed3f34c 36 fields · synced Jun 8, 2026