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510(k) K831566

CUI MAMMARY PROTHESIS SIZER by Cox-Uphuff Intl. — Product Code MRD

K831566 is an FDA 510(k) premarket notification submitted by Cox-Uphuff Intl. for the device "CUI MAMMARY PROTHESIS SIZER". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code MRD (Mammary Sizer), a Class U device. Cox-Uphuff Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
May 16, 1983
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 Cox-Uphuff Intl.

  • K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (December 2, 1987)
  • K874342 — LIGATURE CARRIER/PACKER, HYDROXYLAPATITE (November 13, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K865056 — CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER (May 22, 1987)
  • K871200 — CUI NASAL SEPTUM BUTTON (April 15, 1987)
  • K865033 — BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER (January 12, 1987)
  • K854339 — CUI CHIN SIZER (November 15, 1985)
  • K853945 — CUI RHINOPLASTY IMPLANTS (October 18, 1985)
  • K813394 — DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM (January 22, 1982)
  • K802214 — COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM (October 23, 1980)

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)
  • K203229 — NATRELLE INSPIRA Single Use Sizers for Gel Implants (June 2, 2021)
  • 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)

FDA data resources