# K063688: Surgical Irrigation System, Irrigation Tube

- Pathway: 510(k) (Special)
- Applicant: The Anspach Effort, Inc.
- Decided: Jan 16, 2007 after 35 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852143 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030576: Anspach Irrigation Pump and Irrigation Pump II, The Anspach Effort, Inc. (2003) Summary page 1.

## Indications for use
Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.

Source page: https://510kreport.com/device/K063688
Methodology: https://510kreport.com/methodology