# K935391: Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk Pack

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Feb 24, 1994 after 108 days
- Product code: GFA (Blade, Saw, General & Plastic Surgery, Surgical)
- 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
- Oct 20, 2010 · Not classified · Z-0968-2011: The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterlized but the pro
- Feb 14, 2008 · Not classified · Z-0359-2009: The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.

Source page: https://510kreport.com/device/K935391
Methodology: https://510kreport.com/methodology