Macan

FDA UDI

Class II (US FDA UDI)

by Macan Manufacturing

Identity

Trade Name: Macan FDA UDI
Generic Name: Electrosurgical system FDA UDI
Device Name: Foot Pedal FDA UDI
Model / Reference: 61.102 FDA UDI
Description: Foot Pedal FDA UDI

Identifiers

Primary DI / UDI-DI: 00851708006647 FDA UDI
510(k) Number: K052622 FDA UDI
FDA Product Code: EKZ FDA UDI
GMDN Term: Electrosurgical system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4920 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrosurgical system

Macan by Macan Manufacturing — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Henry Schein — HENRY SCHEIN, INC. · Class II
INTRAcel RF Microneedle System — Jeisys Medical Incorporated · Class II

Cleared under the same submission

K052622 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: Macan Manufacturing

Sources (1)

FDA UDI 8a493c77-42ba-41e8-949d-6129942829b9 35 fields · synced May 30, 2026