# K831756: Anspach 65,000

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Sep 29, 1983 after 120 days
- Product code: HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022907: Anspach Powered Kerrison System (PKS) (2002), 1 descendant of its own
- K954717: Sodem High Speed System for Neurosurgery & Median Sternotomy (1997), 1 descendant of its own
- K062413: Aesculap Pneumatic Kerrison (2006), 0 descendants of its own
- K993851: Sodem Perforator Drive (1999), 0 descendants of its own

## Recalls of this device
- Dec 18, 2006 · Not classified · Z-1039-2008: Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can 

Source page: https://510kreport.com/device/K831756
Methodology: https://510kreport.com/methodology