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510(k) K200706

Sientra OPUS Silicone Gel Breast Implant Sizer by Sientra, Inc. — Product Code MRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2020
Date Received
March 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mammary Sizer
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Sientra, Inc.

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Other clearances for product code MRD

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  • K203229 — NATRELLE INSPIRA Single Use Sizers for Gel Implants (June 2, 2021)
  • K183163 — Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (February 5, 2019)
  • K151055 — Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (May 20, 2015)
  • K131853 — MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (July 17, 2013)
  • K062421 — MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (October 10, 2006)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)
  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
  • K982258 — MAMMARY SIZER (September 8, 1998)