Data / Medical devices / United States / Macan Genesis Manufacturing LLC
Macan Genesis Manufacturing LLC: FDA-registered device maker in Elmwood, WI, United States, 3 510(k) clearances
Macan Genesis Manufacturing LLC is registered with the FDA (registration 1418975) in Elmwood, WI, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 2, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1418975
- Address
- 200 N Main St, Elmwood, WI, United States, 54740
- Owner or operator
- Macan Genesis Manufacturing LLC (10089573)
- Roles
- Manufacturer
- First device listed
- December 19, 2023
- Registered through
- 2026
- Brand names listed
- MACAN Model MC-4A Dental Electrosurgery Unit, Radiosurge MC6A, iSurg (MC6B)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Electrosurgical, And Accessories, Dental | EKZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2017 | K170054 | iSurg | GEI | Substantially Equivalent | Jaco, LLC Dba Macan Manufacturing and Bna Burz North America | accessdata.fda.gov |
| December 9, 2005 | K052622 | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT | EKZ | Substantially Equivalent | Macan Engineering Co. | accessdata.fda.gov |
| May 23, 2005 | K050735 | MC6A | EKZ | Substantially Equivalent | Macan Engineering Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 5, 2006 | 34948 | Not yet classified | Terminated | Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA | The product label fails to warn users to use the device on patients with shielded pacemakers only. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Electrosurgical, And Accessories, Dental
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated October 2, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.