Cleared Special

K203229 - NATRELLE INSPIRA Single Use Sizers for Gel Implants (FDA 510(k) Clearance)

K203229 · Allergan · General & Plastic Surgery device
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Jun 2021
Decision
212d
Days
-
Risk

K203229 is an FDA 510(k) clearance for the NATRELLE INSPIRA Single Use Sizers for Gel Implants. Classified as Mammary Sizer (product code MRD).

Submitted by Allergan (Irvine, US). The FDA issued a Cleared decision on June 2, 2021 after a review of 212 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K203229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2020
Decision Date June 02, 2021
Days to Decision 212 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 114d · This submission: 212d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MRD Mammary Sizer
Device Class -