SAM · Class I · 21 CFR 878.4820

FDA Product Code SAM: Battery-powered Instruments Charged Through Sterile Barriers

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.

Leading manufacturers include Peleton Surgical.

1
Total
1
Cleared
85d
Avg days
2024
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Battery-powered Instruments Charged Through Sterile Barriers Devices (Product Code SAM)

1 devices
1–1 of 1
Cleared Apr 04, 2024
Peleton Universal Single Use Power System and Attachments
K240071
Peleton Surgical
Orthopedic · 85d

About Product Code SAM - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SAM since 2024, with 1 receiving FDA clearance (average review time: 85 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

SAM devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →