# K193608: EBERLE Shaver System C3 and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Eberle GmbH & Co. KG
- Decided: Jan 15, 2021 after 386 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931783 (1993). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092977: Eberle Shaver System Accessories, Efs Eberle Feinwerktechnische Systeme (2010) Summary page 6.
- (no number) EBERLE Shaver System C2 and Shaver Blades: named in the summary without a submission number

## Indications for use
The EBERLE shaver system C3 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone. The EBERLE shaver system accessories are designed to use with the EBERLE shaver system for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone.”

Source page: https://510kreport.com/device/K193608
Methodology: https://510kreport.com/methodology