# K955084: Aspach 65,000 (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Jan 17, 1996 after 90 days
- Product code: HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: 23 (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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 6, 2016 · Class II · Z-1979-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-2017-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1965-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1971-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1941-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1973-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1969-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1980-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-2018-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1977-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1974-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1964-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1967-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1970-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1968-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1972-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1975-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1976-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1963-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- May 8, 2014 · Class II · Z-1983-2014: Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the
- Apr 25, 2013 · Class II · Z-0654-2014: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (
- May 6, 2011 · Class II · Z-0199-2014: Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent rev
- May 18, 2007 · Not classified · Z-1008-2007: The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.

Source page: https://510kreport.com/device/K955084
Methodology: https://510kreport.com/methodology