Identity
- Trade Name
- Microincision Tip FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Microincision Tip, 3cm shaft length, 45 degree angle, 2 pc. FDA UDI
- Model / Reference
- SST-N1-2 FDA UDI
- Description
- Microincision Tip, 3cm shaft length, 45 degree angle, 2 pc. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810026180224 FDA UDI
- 510(k) Number
- K183611 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use 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
MR Unsafe FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Microincision Tip by Soniquence, LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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- CONMED — Conmed Corporation · Class II
Cleared under the same submission
K183611 also covers:
- Dual Footswitch — Soniquence, LLC
- Neutral Plate — Soniquence, LLC
- Neutral Plate — Soniquence, LLC
- RF Generator — Soniquence, LLC
- RF Generator — Soniquence, LLC
- RF Generator — Soniquence, LLC
- RF Generator — Soniquence, LLC
- RF Generator — Soniquence, LLC
- RF Generator — Soniquence, LLC
- RF Generator — Soniquence, LLC
- RF Generator — Soniquence, LLC
- RF Generator — Soniquence, LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Soniquence, LLC
Sources (2)
- FDA UDI 4739ec58-62f1-4130-b6eb-0caeddb0923c 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026