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Erbe

FDA UDI

Class II (US FDA UDI)

by Erbe Elektromedizin GmbH

Identity

Trade Name
ERBE FDA UDI
Generic Name
Inert gas-enhanced endoscopic electrosurgical electrode, single-use FDA UDI
Device Name
APC probe 2200 A, single use OD 3.2mm/9.6Fr; L. 2.2m/7.2ft FDA UDI
Model / Reference
20132-157 FDA UDI
Description
APC probe 2200 A, single use OD 3.2mm/9.6Fr; L. 2.2m/7.2ft FDA UDI

Identifiers

Catalog Number
20132-157 FDA UDI
Primary DI / UDI-DI
04050147020221 FDA UDI
510(k) Number
K013348 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Inert gas-enhanced endoscopic electrosurgical electrode, 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

Dimensions & Sizes

Size
Length — 2.200 Meter FDA UDI

Category: Inert gas-enhanced endoscopic electrosurgical electrode, single-use

Erbe by Erbe Elektromedizin GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inert gas-enhanced endoscopic electrosurgical electrode, single-use.

Cleared under the same submission

K013348 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Erbe Elektromedizin GmbH

Sources (1)

  • FDA UDI bb65f95a-c60c-4601-a863-8f4a5f0f7da5 38 fields · synced Jun 1, 2026