Xcision Medical Systems, LLC

FDA Regulatory Profile

Xcision Medical Systems, LLC appears in FDA public data with 2 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0750-2024, Class II) was initiated on November 30, 2023. Its most recent 510(k) clearance was granted on April 4, 2018.

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0750-2024Class IIGammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030November 30, 2023
Z-2081-2019Class IIGammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod July 3, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K180571GammaPodApril 4, 2018
K172706GammaPod - Model ADecember 22, 2017