# K133604: Anspach EG1 High Speed System, G1 Attachments

- Pathway: 510(k) (Special)
- Applicant: The Anspach Effort, Inc.
- Decided: Jan 10, 2014 after 46 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011444 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011444: Anspach Emax Drill System, The Anspach Effort, Inc. (2001)

## Most influential descendants
- K220485: Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) (2022), 0 descendants of its own

## Recalls of this device
- Dec 7, 2022 · Class II · Z-0917-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Dec 7, 2022 · Class II · Z-0920-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Dec 7, 2022 · Class II · Z-0921-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Dec 7, 2022 · Class II · Z-0916-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Dec 7, 2022 · Class II · Z-0922-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Dec 7, 2022 · Class II · Z-0924-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Dec 7, 2022 · Class II · Z-0918-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Dec 7, 2022 · Class II · Z-0919-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Dec 7, 2022 · Class II · Z-0923-2023: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommend
- Jun 15, 2016 · Class II · Z-2253-2016: The graphics at the attachment interface indicating locked and unlocked position are reversed.
- Dec 10, 2014 · Class II · Z-1037-2015: Customer complaint indicating the color bands on the MIA16-G1 were not correct.

## Indications for use
The Anspach eG I High Speed Electric System is intended for cutting and shaping bone including spine and cranium.

Source page: https://510kreport.com/device/K133604
Methodology: https://510kreport.com/methodology