MACAN GENESIS MANUFACTURING LLC

FDA Device Registration & Listing · Elmwood, WI, US · Registration 1418975

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1418975
FEI Number
1418975
Entity Name
MACAN GENESIS MANUFACTURING LLC
City/State/Country
Elmwood, WI, US
Establishment Address
200 N Main St, Elmwood, WI 54740, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Macan Genesis Manufacturing LLC (Owner Number: 10089573)
Owner / Operator Contact Address
200 N. Main Street, Elmwood, WI 54740, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170054
PMA Number
N/A

All Registered Proprietary Names

MACAN Model MC-4A Dental Electrosurgery Unit Radiosurge MC6A iSurg (MC6B)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EKZ Unit, Electrosurgical, And Accessories, Dental Dental Class 2 872.4920 2023-12-19
EKZ Unit, Electrosurgical, And Accessories, Dental Dental Class 2 872.4920 2023-12-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-01-19

Official Correspondent

Angie Richardson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Macan Genesis Manufacturing LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1418975. Last updated year: 2026. Please use registration number 1418975 when referencing this establishment in official correspondence.
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