Atlas FDA

CUI MAMMARY PROTHESIS SIZER

FDA 510(k) clearance K831566 · decided 1983-08-12

Clearance details

K-number
K831566
Device name
CUI MAMMARY PROTHESIS SIZER
Applicant
Cox-Uphuff Intl.
Decision
Substantially Equivalent
Date received
1983-05-16
Decision date
1983-08-12
Days to decision
88 days
Clearance type
Traditional
Product code
MRD
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K243271)Mentor Worldwide, LLC2025-01-13
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552)Mentor Worldwide, LLC2024-09-06
NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229)Allergan2021-06-02
Sientra OPUS Silicone Gel Breast Implant Sizer (K200706)Sientra, Inc.2020-11-16
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (K183163)Motiva USA, LLC2019-02-05
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
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (K010709)Mentor Corp.2001-04-23
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

Recalls involving this device

RecordFirmDate
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The produ recall (Z-1988-2015)Allergan Inc2015-07-07