# K962087: Servotronic EC100 System

- Pathway: 510(k) (Traditional)
- Applicant: Medicon, Inc.
- Decided: Apr 23, 1997 after 330 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aesculap Microtron System: named in the summary without a submission number
- (no number) Jedmed Fisch Drill System: named in the summary without a submission number

## Indications for use
The Servotronic EC 100 System is intended to be used for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures including maxillofacial surgery, ENT surgery, orthopedic surgery, and plastic surgery.

Source page: https://510kreport.com/device/K962087
Methodology: https://510kreport.com/methodology