# K040186: Anspach Mri Safe Surgical Drill System

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Apr 15, 2004 after 79 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: 7 (0 Class I)
- 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) MicroMax: named in the summary without a submission number
- (no number) original 65K: named in the summary without a submission number

## Recalls of this device
- Oct 6, 2016 · Class II · Z-1942-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1998-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1943-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1997-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1996-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Nov 28, 2012 · Class II · Z-1906-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
- Nov 28, 2012 · Class II · Z-1907-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

## Indications for use
The MRI Safe Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 0.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.

Source page: https://510kreport.com/device/K040186
Methodology: https://510kreport.com/methodology