Cleared Traditional

K200706 - Sientra OPUS Silicone Gel Breast Implant Sizer (FDA 510(k) Clearance)

K200706 · Sientra, Inc. · General & Plastic Surgery device
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Nov 2020
Decision
243d
Days
-
Risk

K200706 is an FDA 510(k) clearance for the Sientra OPUS Silicone Gel Breast Implant Sizer. Classified as Mammary Sizer (product code MRD).

Submitted by Sientra, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on November 16, 2020 after a review of 243 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sientra, Inc. devices

Submission Details

510(k) Number K200706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2020
Decision Date November 16, 2020
Days to Decision 243 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 114d · This submission: 243d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRD Mammary Sizer
Device Class -