Home / 510(k) Clearances / K203229

510(k) K203229

NATRELLE INSPIRA Single Use Sizers for Gel Implants by Allergan — Product Code MRD

K203229 is an FDA 510(k) premarket notification submitted by Allergan for the device "NATRELLE INSPIRA Single Use Sizers for Gel Implants". The FDA issued a decision of Substantially Equivalent on June 2, 2021. The device falls under product code MRD (Mammary Sizer), a Class U device. Allergan has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2021
Date Received
November 2, 2020
Clearance Type
Special
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 Allergan

  • K193589 — TrueTear Intranasal Tear Neurostimulator (August 31, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)
  • DEN170086 — TrueTear Intranasal Tear Neurostimulator (May 17, 2018)
  • K161457 — XEN Glaucoma Treatment System (November 21, 2016)
  • K143354 — Natrelle 133 Plus Tissue Expander (August 20, 2015)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)
  • K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS (July 9, 2009)
  • K051852 — SINGLE AMPLIFIER FOR BOTOX (September 14, 2005)

Other clearances for product code MRD

  • K243271 — MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ (January 13, 2025)
  • K241552 — MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (September 6, 2024)
  • K200706 — Sientra OPUS Silicone Gel Breast Implant Sizer (November 16, 2020)
  • 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)

FDA data resources