# K022942: Craniocut

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Oct 21, 2002 after 46 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931783 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980686: Aesculap Hilan Motor System, Aesculap, Inc. (1998) Summary page 1.
- K003612: Microspeed EC Motorsystem GD650/GD653, Aesculap, Inc. (2001)
- K014060: Microaire 1000E System, Microaire Surgical Instruments, Inc. (2002) Summary page 1.
- K984035: XK-95 High Speed Motor Drill System, Komet Medical (1999) Summary page 1.
- K002903: Anspach Angled Micronose Attachment, The Anspach Effort, Inc. (2000) Summary page 1.
- K011444: Anspach Emax Drill System, The Anspach Effort, Inc. (2001)
- K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System, Medtronic Midas Rex (2002) Summary page 1.

## Indications for use
Aesculap's Craniocut is intended for use in cutting bone in craniotomies.

Source page: https://510kreport.com/device/K022942
Methodology: https://510kreport.com/methodology