SAMClass I
Battery-Powered Instruments Charged Through Sterile Barriers
21 CFR 878.4820 / General, Plastic Surgery
SAM is the FDA product code for Battery-Powered Instruments Charged Through Sterile Barriers, a class I device type, regulated under 21 CFR 878.4820. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SAM
- Device name
- Battery-Powered Instruments Charged Through Sterile Barriers
- FDA 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.
- Regulation
- 21 CFR 878.4820
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SAM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code SAM| Applicant | Clearances |
|---|---|
| Peleton Surgical | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.