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LigaSure

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
LigaSure FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Device Name
Curved Jaw, Open Sealer/Divider Electrode FDA UDI
Model / Reference
LF3225 FDA UDI
Description
Curved Jaw, Open Sealer/Divider Electrode FDA UDI

Identifiers

Primary DI / UDI-DI
10884521780545 FDA UDI
510(k) Number
K160331 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery 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

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 25 Centimeter FDA UDI
Width — 2.5 Centimeter FDA UDI

Category: Open-surgery 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 Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.

Cleared under the same submission

K160331 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 5703fefe-fd5e-4604-a6d0-d1e557f25070 37 fields · synced May 31, 2026