Battery-Powered Instruments Charged Through Sterile Barriers
Battery-powered instruments charged through sterile barriers are surgical power tools intended for use during surgical procedures to operate accessories or attachments such as saw blades, drill chucks, pin drivers, and reamers to cut hard tissues (bone) and soft tissues, with the unique feature of being chargeable without breaching the sterile field. They are classified as FDA Class I (general controls, no 510(k) required) under regulation 878.4820 in the General and Plastic Surgery specialty, with product code SAM. The device is not an implant and does not support life-sustaining functions.
Basic Information
- Product Code
- SAM
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240071 | Peleton Universal Single Use Power System and Attachments | Apr 04, 2024 | Substantially Equivalent | Peleton Surgical |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.