Identity
- Trade Name
- Medtronic FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- ProdiGI Single Use Electrosurgical Knife/ProdiGI Multi-Functional Electrosurgical Knife FDA UDI
- Model / Reference
- EKM-417D FDA UDI
- Description
- ProdiGI Single Use Electrosurgical Knife/ProdiGI Multi-Functional Electrosurgical Knife FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948318946778 FDA UDI
- 510(k) Number
- K212999 FDA UDI
- FDA Product Code
- KNS FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 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
MR Unsafe FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Medtronic by Anrei Medical(HZ) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.
- GeniSurge — Genicon · Class II
- Single Use Electrosurgical Knife — Micro-Tech (Nanjing) Co., Ltd. · Class II
- BE-ST ElectroCautery Pencil — LACEY MANUFACTURING COMPANY LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Short Throw — US Endoscopy · Class II
- Single Use Electrosurgical Knife KD-655 — Olympus Medical Systems Corporation · Class II
- Polyp Pak — US Endoscopy · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Cleared under the same submission
K212999 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Anrei Medical(HZ) Co., Ltd.
Sources (1)
- FDA UDI cc900e1e-1a80-4dd8-9be6-115a8509faf8 34 fields · synced May 30, 2026