FDA product code SAM: Battery-Powered Instruments Charged Through Sterile Barriers
SAM is the FDA product code for battery-powered instruments charged through sterile barriers. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under SAM, 1 in the last five years. The average 510(k) review took 85 days (median 85); 85 days on average over the last three years.
Definition
Battery-powered instruments intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissues (bones) and soft tissues. Accessories or attachments may include saw blades, drill chuck, pin driver, and reamer.
Classification
| Field | Value |
|---|---|
| Device name | Battery-Powered Instruments Charged Through Sterile Barriers |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for SAM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 85 |
Compare with all 510(k) review times · Search every SAM clearance
Top SAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Peleton Surgical | 1 | 2024-04-04 |
Most recent SAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240071 | Peleton Surgical | Peleton Universal Single Use Power System and Attachments | 2024-04-04 | 85 |
Recalls for SAM devices
openFDA lists no recalls for product code SAM.
Frequently asked questions
What is FDA product code SAM?
SAM is the FDA product code for battery-powered instruments charged through sterile barriers. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel.
What device class is SAM?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAM?
Across 1 cleared submissions the average was 85 days from receipt to decision (median 85).
Which companies have the most SAM clearances?
Peleton Surgical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAM
- Run a recall and safety report across every SAM manufacturer
- Watch product code SAM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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