# K050735: MC6A

- Pathway: 510(k) (Traditional)
- Applicant: Macan Engineering Co.
- Decided: May 23, 2005 after 63 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950239 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955176: Dento-Surge, Ellman Intl., Inc. (1996) Summary page 1.
- K950239: Sensimatic 500SE, Parkell, Inc. (1995) Summary page 1.

## Most influential descendants
- K170054: iSurg (2017), 0 descendants of its own
- K052622: Macan Model MC-4A Dental Electrosurgical Unit (2005), 0 descendants of its own

## Indications for use
Soft tissue management within the oral cavity to address the indications for incision, excision and coagulation to induce hemostasis in intra-oral soft tissue.

Source page: https://510kreport.com/device/K050735
Methodology: https://510kreport.com/methodology