510(k) · Cleared
Recalled · 2010Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Health Care, Sarns · GFA Blade, Saw, General & Plastic Surgery, Surgical
Cleared on Feb 24, 1994 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.
- Decided
- Feb 24, 1994
- Review
- 108 days
- Class
- Class I
- Product code
- GFA
- Recalls
- 2
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GFA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2010 | Not classified | Z-0968-2011 | Labeling design | 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 product actually was sterilzed with gamma… |
| Feb 14, 2008 | Not classified | Z-0359-2009 | Nonconforming Material/Component | 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. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All GFA devicesGFA Blade, Saw, General & Plastic Surgery, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GFA
FDA has decided no GFA device since 2007.
Median 510(k) review, days · GFA
Too few GFA 510(k)s in any year since 2007 to give a median.
Recalls per year · GFA
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GFA
381in 2025
MAUDE reports naming product code GFA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 13 |
| 2008 | 0 | — | 7 | 94 |
| 2009 | 0 | — | 1 | 154 |
| 2010 | 0 | — | 2 | 221 |
| 2011 | 0 | — | 1 | 247 |
| 2012 | 0 | — | 0 | 249 |
| 2013 | 0 | — | 0 | 338 |
| 2014 | 0 | — | 0 | 378 |
| 2015 | 0 | — | 2 | 375 |
| 2016 | 0 | — | 0 | 232 |
| 2017 | 0 | — | 0 | 284 |
| 2018 | 0 | — | 0 | 254 |
| 2019 | 0 | — | 0 | 331 |
| 2020 | 0 | — | 0 | 276 |
| 2021 | 0 | — | 0 | 394 |
| 2022 | 0 | — | 1 | 442 |
| 2023 | 0 | — | 0 | 383 |
| 2024 | 0 | — | 0 | 501 |
| 2025 | 0 | — | 0 | 381 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935391: Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935391
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026