Identity
- Trade Name
- Ligasure FDA UDI
- Generic Name
- Electrosurgical handpiece, reusable FDA UDI
- Device Name
- Tissue Fusion Open Instrument,Curved Jaw, Reusable FDA UDI
- Model / Reference
- LS3110 FDA UDI
- Description
- Tissue Fusion Open Instrument,Curved Jaw, Reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884524002712 FDA UDI
- 510(k) Number
- K981916 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical handpiece, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 2.8 Centimeter FDA UDI
Category: Electrosurgical handpiece, reusable
Ligasure by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K981916 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
- Covidien LP
Sources (1)
- FDA UDI 078eeb94-8746-4fb3-bb10-dec2d9d6030e 37 fields · synced Jun 1, 2026