Search Results
Found 21 results
510(k) Data Aggregation
K Number
K233500Device Name
Benesta Tissue Removal Device
Manufacturer
Caldera Medical, Inc.
Date Cleared
2023-11-30
(30 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
Caldera Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Caldera Medical BenestaTM Tissue Removal Device is intrauterine use by trained surgeons to hysteroscopically resect and remove tissue, such as: submucous myomas, endometrial polyps, and retained products of conception.
Device Description
Not Found
Ask a Question
K Number
K211975Device Name
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
Manufacturer
Caldera Medical, Inc.
Date Cleared
2021-11-10
(138 days)
Product Code
OTN, PWJ
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Caldera Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Desara TV EZ and Desara Blue TV EZ are intended to be used in females to position a mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The 3.0mm or 2.7mm surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara TV EZ and Desara Blue TV EZ surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Device Description
The Desara TV EZ and Desara Blue TV EZ Systems are comprised of sterile, single-use midurethral slings used to provide support in the pelvic region to treat female stress urinary or mixed incontinence and a stainless steel disposable introducer in either a 3.0mm or 2.7mm diameter. The devices are intended to be used in females, via the transvaginal surgical approach in the in-patient or out-patient clinical setting.
Desara TV EZ and Desara Blue TV EZ slings are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices include mesh placement aides consisting of: integral sleeves over the mesh, a removable EZ tab midline indicator and dilator tubes at each end of the device which attach to the 3.0mm or 2.7mm transvaqinal surqical introducer for placement of the mesh. All placement aids are removed after the device is positioned and only the mesh portion of the device remains as a permanent implant.
Ask a Question
K Number
K192811Device Name
BenestaTM Tissue Removal Device
Manufacturer
Caldera Medical, Inc.
Date Cleared
2020-10-23
(389 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
Caldera Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Caldera Medical Benesta™ Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
Device Description
Not Found
Ask a Question
K Number
K192822Device Name
Benesta Hysteroscope
Manufacturer
Caldera Medical, Inc.
Date Cleared
2020-09-09
(344 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
Caldera Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Benesta ™ Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Device Description
Not Found
Ask a Question
K Number
K191416Device Name
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
Manufacturer
Caldera Medical, Inc.
Date Cleared
2020-02-07
(255 days)
Product Code
PAH, PWJ
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Caldera Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Desara One mid-urethral mesh implant is intented for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
The Desara One introducer is intended for the placement of the Desara One single incision mesh implant.
Device Description
Desara® One Single Incision Sling System
Ask a Question
K Number
K172614Device Name
Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left
Manufacturer
Caldera Medical, Inc.
Date Cleared
2018-05-04
(246 days)
Product Code
PWJ
Regulation Number
884.4910Why did this record match?
Applicant Name (Manufacturer) :
Caldera Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Caldera Medical surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence.
Caldera Medical Outside-In introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL), Desara® Blue SS (CAL-DS01BS)
Caldera Medical Inside-Out introducers may be used with or without the Winged Guide Accessory with the following Desara implants:
Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL)
Caldera Medical Suprapubic introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® Blue SS (CAL-DS01BS)
Caldera Medical Transvaginal introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV)
Desara® TV (CAL-DS01TV), Desara® Blue TV (CAL-DS01BTV) implants may only be used with Caldera Medical Transvaginal introducers, CAL-TV32
Device Description
Not Found
Ask a Question
K Number
K162201Device Name
Desara TV, Desara Blue TV
Manufacturer
CALDERA MEDICAL, INC.
Date Cleared
2017-01-11
(159 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
CALDERA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Desara® TV and Desara® Blue TV are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Device Description
Not Found
Ask a Question
K Number
K150016Device Name
Vertessa Lite
Manufacturer
CALDERA MEDICAL, INC.
Date Cleared
2015-04-06
(91 days)
Product Code
OTO
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
CALDERA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vertessa® Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or laparoscopic abdominal procedures.
Device Description
Vertessa® Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa "Lite will be available in a rectangular flat sheet mesh and rectangular strip mesh designs.
The flat sheet mesh designs are available in the following sizes: 8 x 16 cm, 8 x 18 cm, 8 x 20 cm, 8 x 22 cm, 8 x 24 cm, 8 x 26 cm, 10 x 16 cm, 10 x 18 cm, 10 x 20 cm, 10 x 22 cm, 10 x 24 cm, 10 x 26 cm, and 11 x 30 cm.
The strip mesh designs are available in the following sizes: 4 x 16 cm, 4 x 18 cm, 4 x 20 cm, 4 x 22 cm, 4 x 24 cm, 4 x 26 cm, 5 x 18 cm, 5 x 20 cm, 5 x 20 cm, 5 x 22 cm, 5 x 24 cm, 5 x 26 cm, and 6 x 30 cm.
Ask a Question
K Number
K150023Device Name
Vertessa Lite Y-Mesh
Manufacturer
CALDERA MEDICAL, INC.
Date Cleared
2015-04-06
(90 days)
Product Code
OTO
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
CALDERA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vertessa® Lite Y-Mesh may be used a bridging material for as sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.
Device Description
Vertessa® Lite Y-Mesh devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite Y-Mesh devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit clear mesh. Vertessa® Lite Y-Mesh will be available in a y-shape design of five different sizes (22 x 4 x 3 cm, 22 x 4 x 4 cm, 22 x 5 x 4 cm, 26 x 4 x 3 cm, 26 x 5 x 4 cm).
Ask a Question
K Number
K132069Device Name
DESARA MESH, DESARA BLUE
Manufacturer
CALDERA MEDICAL, INC.
Date Cleared
2013-09-23
(82 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
CALDERA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Desara® and Desara® Blue devices are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Device Description
Desara and Desara® Blue devices are sterile, single-use mid-urethral slings used to provide support in the pelvic region to treat stress urinary or mixed incontinence. The devices are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices have integral sleeves, tips and sutures to assist the surgeon in placement of the mesh, which are removed after placement of the device.
Desara® and Desara® Blue are designed to work with Caldera Medical's reusable introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach.
Ask a Question
Page 1 of 3