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510(k) K961356

MAMMARY SIZER by General Surgical Innovations — Product Code MRD

K961356 is an FDA 510(k) premarket notification submitted by General Surgical Innovations for the device "MAMMARY SIZER". The FDA issued a decision of SN on September 23, 1996. The device falls under product code MRD (Mammary Sizer), a Class U device. General Surgical Innovations has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 23, 1996
Date Received
April 8, 1996
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 General Surgical Innovations

  • K983318 — FIXATION SYSTEM (March 1, 1999)
  • K973046 — SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, (January 16, 1998)
  • K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (November 14, 1997)
  • K970201 — GSI CANNULA WITH INTRODUCER (April 21, 1997)
  • K962702 — SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION A (February 19, 1997)
  • K952278 — THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA (August 7, 1995)
  • K951878 — SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA (June 29, 1995)
  • K944418 — THE SPACEMAKER AND THE SPACEMAKER II (November 1, 1994)
  • K944536 — GSI KNOTMAKER (October 5, 1994)
  • K943671 — GSI CANNULA REDUCER ACCESSORY (August 9, 1994)

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