Electrode Handpiece, Foot Activated

FDA UDI

Class II (US FDA UDI)

by Gynex Corporation

Identity

Trade Name: Electrode Handpiece, Foot Activated FDA UDI
Generic Name: Electrocautery system handpiece FDA UDI
Model / Reference: 950 FDA UDI

Identifiers

Primary DI / UDI-DI: GYNX9501 FDA UDI
510(k) Number: K040780 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrocautery system handpiece 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocautery system handpiece

Electrode Handpiece, Foot Activated by Gynex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocautery system handpiece.

Bovie — BOVIE MEDICAL CORPORATION · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
IMCO — INDEPENDENT MEDICAL CO-OP, INC. · Class II
Geiger TCU Handpiece — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Bovie — BOVIE MEDICAL CORPORATION · Class II
Pro Advantage — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class II

Cleared under the same submission

K040780 also covers:

Electrode Handpiece, Hand Activated — GYNEX CORPORATION

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: Gynex Corporation

Sources (1)

FDA UDI 0da054c9-8c4e-4616-9eb3-9909546ef51f 33 fields · synced Jun 1, 2026