Identity
- Trade Name
- Bipolar HF cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- 390 863 000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082013022 FDA UDI
- 510(k) Number
- K971881 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrical-only medical device connection cable, reusable
Bipolar HF cable by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
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- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
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- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K971881 also covers:
- Bipolar HF cable — SOPRO-COMEG GmbH
- Bipolar HF cable — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOPRO-COMEG GmbH
Sources (1)
- FDA UDI 4662c30e-fa39-4dd6-b57d-b92d9e11fe72 33 fields · synced Jun 8, 2026