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Sientra, Inc.

FDA Regulatory Profile

Sientra, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on June 8, 2023.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K214124AlloX2 Pro Tissue ExpandersJune 8, 2023
K221127Sientra, inc. PortfinderMay 10, 2023
K200706Sientra OPUS Silicone Gel Breast Implant SizerNovember 16, 2020

FDA data resources