Home / 510(k) Clearances / K982258

510(k) K982258

MAMMARY SIZER by Specialty Surgical Products, Inc. — Product Code MRD

K982258 is an FDA 510(k) premarket notification submitted by Specialty Surgical Products, Inc. for the device "MAMMARY SIZER". The FDA issued a decision of Substantially Equivalent on September 8, 1998. The device falls under product code MRD (Mammary Sizer), a Class U device. Specialty Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1998
Date Received
June 26, 1998
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 Specialty Surgical Products, Inc.

  • K140383 — ALLOX2 TISSUE EXPANDERS (October 28, 2014)
  • K070303 — SILICONE TISSUE EXPANDER (June 22, 2007)
  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
  • K983015 — VIRILIS PENILE PROSTHESIS (February 5, 1999)
  • K982065 — STERILE SILICONE EXTERNAL WOUND COVER (August 12, 1998)
  • K982067 — MAGNETIC PORT SILICONE TISSUE EXPANDER (July 13, 1998)
  • K974653 — SILICONE ELASTOMER SHEETING (March 13, 1998)
  • K974654 — SILICONE BLOCKS (February 24, 1998)
  • K974209 — SILICONE TISSUE/INFLATABLE TISSUE EXPANDER (February 6, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)

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