Battery-Powered Instruments Charged Through Sterile Barriers

SAM · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4820

Classification

FDA Product Code: SAM
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 878.4820
Review panel: OR
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown