SUMMA THERAPEUTICS, LLC

FDA Regulatory Profile

SUMMA THERAPEUTICS, LLC appears in FDA public data with 1 recall, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1704-2026, Class II) was initiated on July 21, 2025. Its most recent 510(k) clearance was granted on July 16, 2024.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1704-2026Class IIBrand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/CataJuly 21, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K241740Finesse Injectable™ PTA Balloon Dilatation CatheterJuly 16, 2024
K230263Finesse™ Injectable PTA Balloon Dilatation CatheterMay 26, 2023
K150452ComboCath OTW PTA Dilatation CatheterAugust 13, 2015