Cleared Traditional

K221127 - Sientra, inc. Portfinder
(FDA 510(k) Clearance)

K221127 · Sientra, Inc. · General & Plastic Surgery

May 2023

Decision

387d

Days

—

Risk

K221127 is an FDA 510(k) clearance for the Sientra, inc. Portfinder. This device is classified as a Tissue Expander And Accessories.

Submitted by Sientra, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on May 10, 2023, 387 days after receiving the submission on April 18, 2022.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K221127 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2022
Decision Date	May 10, 2023
Days to Decision	387 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF