Product code SAM

Device name

Battery-Powered Instruments Charged Through Sterile Barriers

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.4820

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset