# K781979: Surgairtome Two

- Pathway: 510(k) (Traditional)
- Applicant: American Sterilizer Co.
- Decided: Dec 20, 1978 after 23 days
- Product code: HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: 2 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 9, 2007 · Not classified · Z-0711-2008: Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.
- Aug 26, 2004 · Not classified · Z-0041-05: The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.

Source page: https://510kreport.com/device/K781979
Methodology: https://510kreport.com/methodology