Identity
- Trade Name
- HybridKnife® I-Type I-Jet EUDAMEDERBE FDA UDI
- Generic Name
- Endoscopic electrosurgical submucosal lift/resection instrument FDA UDI
- Device Name
- HybridKnife probes EUDAMEDHybridKnife® I-Type I-Jet OD 2.3mm; L 1.9m FDA UDI
- Model / Reference
- 20150-261 EUDAMEDFDA UDI
- Description
- HybridKnife® I-Type I-Jet OD 2.3mm; L 1.9m FDA UDI
Identifiers
- Catalog Number
- 20150-261 FDA UDI
- Primary DI / UDI-DI
- 04050147018365 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050147018365 EUDAMED
- 510(k) Number
- K083608 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical submucosal lift/resection instrument FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 1.900 Meter FDA UDI
Category: Endoscopic electrosurgical submucosal lift/resection instrument
Erbe by Erbe Elektromedizin GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical submucosal lift/resection instrument.
- ORISE™ ProKnife — Boston Scientific · Class II
- ORISE™ ProKnife — Boston Scientific · Class II
- ORISE™ ProKnife — Boston Scientific · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
Cleared under the same submission
K083608 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
Sources (2)
- FDA UDI 1414af2d-e8b6-4c26-8564-20e01c5dea3c 38 fields · synced Jul 17, 2026
- EUDAMED ff258589-ff75-4e86-ac02-4ff0f36499a3 61 fields · synced Jul 17, 2026