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510(k) Data Aggregation
K Number
K062421Device Name
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
Manufacturer
MENTOR CORPORATION
Date Cleared
2006-10-10
(53 days)
Product Code
MRD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MENTOR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.
Device Description
The Mentor Resterilizable Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ breast implant size and shape for each patient prior to implantation of a breast implant. It is provided non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times.
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K Number
K053296Device Name
MENTOR ARIS SUPRAPUBIC SURGICAL KIT
Manufacturer
MENTOR CORPORATION
Date Cleared
2005-12-15
(20 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
MENTOR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Aris Suprapubic Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description
The Mentor Aris Suprapubic Surgical Kit consists of two components: the Mentor Aris Sling and a set of Introducers. The Mentor Aris Sling is an implantable, suburcthral, support tape made from knitted monofilament polypropylene fibers. Two sterile, disposable flat curved Introducers necessary for implantation of the sling are also included in the Surgical Kit. The Introducers consist of a stainless steel needle with a plastic handle.
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K Number
K052440Device Name
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
Manufacturer
MENTOR CORPORATION
Date Cleared
2005-10-11
(35 days)
Product Code
EZD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
MENTOR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode
Device Description
The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.
The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.
The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.
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K Number
K050148Device Name
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT
Manufacturer
MENTOR CORPORATION
Date Cleared
2005-03-09
(44 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
MENTOR CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Aris Trans-obturator Surgical Kit consists of the Mentor Aris Trans-obturator Tape, an implantable, suburethral, support tape, plus introducers. The Tape and the Surgical Kit are indicated for the surgical treatment of all types of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description
The Mentor Aris Trans-obturator Kit consists of two components: the Mentor Aris Transobturator Tape and a set of introducer needles.
The Mentor Aris Trans-obturator Tape is an implantable, suburethral, support tape made from knitted monofilament polypropylene fibers. This structure gives the Aris Tape resistance to traction, allows tissue colonization and facilitates positioning during surgery.
A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Surgical Kit.
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