# K955599: Stryker Femoral Canal Sponge & Acetabulum Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Feb 22, 1996 after 76 days
- Product code: GDY (Gauze/Sponge, Internal, X-Ray Detectable)
- Device class: 1
- Regulation: 21 CFR 878.4450
- Recalls of this device: 5 (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
- Jan 25, 2010 · Not classified · Z-1104-2010: The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-ste
- Jan 25, 2010 · Not classified · Z-1105-2010: The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-ste
- Jan 25, 2010 · Not classified · Z-1108-2010: The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-ste
- Jan 25, 2010 · Not classified · Z-1107-2010: The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-ste
- Jan 25, 2010 · Not classified · Z-1106-2010: The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-ste

Source page: https://510kreport.com/device/K955599
Methodology: https://510kreport.com/methodology