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Disposable Monopolar Handswitching Pencil

FDA UDI

Class II (US FDA UDI)

by Avante

Identity

Trade Name
Disposable Monopolar Handswitching Pencil FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Model / Reference
P00507 FDA UDI

Identifiers

Primary DI / UDI-DI
00815871020091 FDA UDI
510(k) Number
K002257 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/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

No

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

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

Disposable Monopolar Handswitching Pencil by Avante — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.

Cleared under the same submission

K002257 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avante

Sources (1)

  • FDA UDI e4cd08a1-0a54-4503-8f40-329d4f43fc49 34 fields · synced Jun 8, 2026