← Back to catalogue

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
FiAPC® plus A; OD 2.3mm; L 3.0m; 3000 Straight Fire flexible probe w/ filter FDA UDI
Model / Reference
20132-323 FDA UDI
Description
FiAPC® plus A; OD 2.3mm; L 3.0m; 3000 Straight Fire flexible probe w/ filter FDA UDI

Identifiers

Catalog Number
20132-323 FDA UDI
Primary DI / UDI-DI
04050147023611 FDA UDI
510(k) Number
K242044 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 — 3.0 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

K242044 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
Erbe Elektromedizin GmbH

Sources (1)

  • FDA UDI ae69a903-0dbc-4010-93da-344548134265 38 fields · synced Jun 7, 2026