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
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.