Atlas FDA

MENTOR STERILE SALINE MAMMARY VOLUME SIZERS

FDA 510(k) clearance K010709 · decided 2001-04-23

Clearance details

K-number
K010709
Device name
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
Applicant
Mentor Corp.
Decision
Substantially Equivalent
Date received
2001-03-09
Decision date
2001-04-23
Days to decision
45 days
Clearance type
Traditional
Product code
MRD
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Santa Barbara, CA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (K151055)Mentor Worldwide, LLC2015-05-20
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (K131853)Mentor Worldwide, LLC2013-07-17
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (K062421)Mentor Corporation2006-10-10
MAMMARY SIZER, MAMMARY PROTHESIS SIZER (K984106)Specialty Surgical Products, Inc.1999-02-12
MAMMARY SIZER (K982258)Specialty Surgical Products, Inc.1998-09-08
MAMMARY SIZER (K961356)General Surgical Innovations1996-09-23
CUI MAMMARY PROTHESIS SIZER (K831566)Cox-Uphuff Intl.1983-08-12

Recalls involving this device

RecordFirmDate
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Brea recall (Z-2591-2014)Mentor Texas, LP.2014-09-04

PMA approvals by this applicant

RecordFirmDate
MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants (P030053/S084)Mentor Corp.2025-12-17
MemoryGel™ Silicone Gel-Filled Breast Implants (P030053/S080)Mentor Corp.2025-08-12
MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants (P030053/S082)Mentor Corp.2025-08-08
Mentor MemoryGel® Breast Implants (P030053/S072)Mentor Corp.2025-08-06
MENTOR MemoryGel Enhance Breast Implants (P030053/S077)Mentor Corp.2025-07-03
MENTOR™ MemoryGel™ Enhance Breast Implants (P030053/S081)Mentor Corp.2025-06-18
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053/S079)Mentor Corp.2025-05-21
MENTOR™ MemoryGel™ Enhance Breast Implants (P030053/S078)Mentor Corp.2025-02-14