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Erbe

FDA UDI

Class II (US FDA UDI)

by Erbe Elektromedizin GmbH

Identity

Trade Name
ERBE FDA UDI
Generic Name
Endoscopic electrosurgical submucosal lift/resection instrument FDA UDI
Device Name
HYBRIDknife® flex I-Type E-long; OD 2.6mm; L 2.3m FDA UDI
Model / Reference
20150-113 FDA UDI
Description
HYBRIDknife® flex I-Type E-long; OD 2.6mm; L 2.3m FDA UDI

Identifiers

Primary DI / UDI-DI
04050147022973 FDA UDI
510(k) Number
K232033 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical submucosal lift/resection instrument 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 — 2.3 Meter FDA UDI

Category: Endoscopic electrosurgical submucosal lift/resection instrument

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

Similar devices

Also classified as Endoscopic electrosurgical submucosal lift/resection instrument.

Cleared under the same submission

K232033 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 660e5fe7-781a-4eea-adab-9142027b651d 37 fields · synced May 30, 2026