FDA applicant

Sientra, Inc.

Santa Barbara, CA3 decisions2020–20230 recalls

FDA records 3 decisions for Sientra, Inc. (Santa Barbara, CA) from 2020 to 2023: 3 510(k) clearances. Most are in product codes LCJ (Tissue Expander And Accessories) and MRD (Mammary Sizer). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Sientra, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020high 2 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Sientra, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sientra, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Sientra, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?