Standard Bariatrics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K231603Standard Staple-Line Reinforcement (SSLR23)October 6, 2023
K222085Standard Tapered Bougie, 38 Fr.October 31, 2022
K212728Standard Bougie, 38 Fr. and Hand PumpSeptember 23, 2021
K210437Standard Bougie, 38 Fr.June 29, 2021
K210278Titan SGSApril 28, 2021
K200517Standard TrocarApril 9, 2020
K191885Standard BougieApril 8, 2020
K190788Disposable Standard ClampApril 18, 2019
K181608Disposable Standard ClampSeptember 27, 2018
K170379Disposable Standard ClampJuly 19, 2017
K161720Standard ClampOctober 24, 2016
K153358Standard ClampMay 2, 2016