Identity
- Trade Name
- SP-Tip EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Malleable Tip EUDAMED1/8" Pin Electrode, Hex Key Adaptor (1 pc) FDA UDI
- Model / Reference
- SFT-S EUDAMEDSPIN EUDAMEDFDA UDI
- Description
- 1/8" Pin Electrode, Hex Key Adaptor (1 pc) FDA UDI
Identifiers
- Catalog Number
- SPIN FDA UDI
- Primary DI / UDI-DI
- 00810026180996 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081002618SFT-SKJ EUDAMED
- 510(k) Number
- K183611 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France 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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
SP-Tip by Soniquence, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; PL — XODUS MEDICAL, INC. · Class II
- star Bipolar RF Electrode — STARMED CO., LTD · Class IIb
- 4" Blade Tip Ext Ins; Stainless Steel; Blue Ins; Black Ext Ins — XODUS MEDICAL, INC. · Class II
- VIVA RF electrode — STARMED CO., LTD · Class IIb
- CONMED — Conmed Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081002618SFT-SKJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7aaab8d8-56cd-48aa-a993-3f548c1eb2d3 61 fields · synced Jul 16, 2026
- FDA UDI e80f1966-74b5-44a8-aa2c-3053f35c6d7c 35 fields · synced May 29, 2026