SAM

Battery-Powered Instruments Charged Through Sterile Barriers

Product code

SAM

Device name

Battery-Powered Instruments Charged Through Sterile Barriers

Device class

Class 1

21 CFR

21 CFR 878.4820

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-04.

1 summaries are archived here for direct download.