Identity
- Trade Name
- Ligasure FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Tissue Fusion Electrode,Curved Jaw FDA UDI
- Model / Reference
- LS3092 FDA UDI
- Description
- Tissue Fusion Electrode,Curved Jaw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884524002156 FDA UDI
- 510(k) Number
- K981916 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, 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 Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 2.5 Centimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Ligasure by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, single-use.
- ARIS COBLATION Turbinate Reduction Wand — Smith & Nephew, Inc. · Class II
- AESCULAP — AESCULAP, INC. · Class II
- BE-ST Bipolar Forceps Straight — LACEY MANUFACTURING COMPANY LLC · Class II
- Coblation — Smith & Nephew, Inc. · Class II
- Burs — JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- PLASMASORD — Gyrus Acmi, Inc. · Class II
- CoolSeal™ Trinity — Justright Surgical · Class II
- Bi-Tip™ Flextrode™ — ELLIQUENCE LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI eeddc269-1c65-4b6f-8675-fb2055637d42 37 fields · synced Jun 8, 2026