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510(k) Data Aggregation
K Number
K152619Device Name
Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
Manufacturer
PROSURG, INC.
Date Cleared
2016-04-29
(228 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prosurg's Neoscope 3D™ -3D Digital Video Endoscopic System ( Rigid & Flexible) is intended to provide "Real -Time" 3D images and video to surgeons for endoscopic examination, diagnosis and treatment for Minimally Invasive surgical Procedures within Abdominal and Female Reproductive organs, using surgical devices and accessories.
Device Description
The Neoscope 3D™ -3D Digital Video Endoscope design consists of two CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end, connecting wires along the length of the hollow tubular structure and a USB / HD Connector at the proximal end. The distal end of the 3D Endoscope containing two CMOS sensors and LEDs / Fiber optic is protected by sealed, clear window to prevent any fluid passageway within 3D Endoscope. The NeoScope flex 3D ™ - Flexible Video Endoscopic device is designed with Articulating / Deflecting Distal tip controlled by lever mechanism in the handle.
The Single Use. NeoScope 3D™ - Rigid and Flexible models are provided sterile for use by physician. The Rigid Neoscope 3D is designed to provide zero (0) degree, thirty (30) degree and forty five (45) degree field of view. The Neoscope flex 3D™ Flexible endoscope is designed to provide minimum 90 degree tip deflection & field of view.
The NeoScope 3D ™- 3D Digital Video Endoscopic System (Rigid / Flexible) consists of four main components:
(a) Digital Video Endoscope with two CMOS Sensor & Built-in LEDs / Fiber optic in Stainless steel Tube. Or Single Use, NeoScope flex 3D- Flexible Endoscope with Articulating / Deflecting Distal Tip. (Patient Contact Item)
(b) Video Processing Module with USB 2.0 / 3.0 / HD / DVI connecting ports. (Commercially Available, Non -Patient contact item)
(c) 3D Laptop /Tablet computer with windows Operating System, 3D Monitor / 3D TV, USB 2.0 /3.0 / HD / S-Video Connecting Cables. (Commercially Available, Non- patient contact item)
The Single Use Neoscope 3D Video Endoscope consists of CMOS (2) imaging sensors & LED mounted at the distal tip. The 3D Laptop / Tablet computers is designed to power Imaging Sensors and LED. The Neoscope 3D is provided Sterile, for Single use only.
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K Number
K120766Device Name
ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
Manufacturer
PROSURG, INC.
Date Cleared
2012-09-11
(182 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prosurg's NeoScope (Cystourethroscope /Cystoureteroscope /Cystonephroscope/ Digital Video System (which includes the Digital video Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Urinary tract, and can be percutaneously to examine the interior of the kidney and using additional accessories can be used to perform various diagnostic and therapeutic procedures.
The Prosurg's Neoscope (Hysteroscopce) Digital Video System (which includes the Digital Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Gynecological tract, and can be percutaneously to examine the interior of the uterus and using additional accessories can be used to perform various diagnostic and therapeutic procedures.
Device Description
Not Found
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K Number
K072528Device Name
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
Manufacturer
PROSURG, INC.
Date Cleared
2007-12-28
(112 days)
Product Code
JEY
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children.
Specific Indications for Use:
- . Fractures of the cranium, mid-face, maxilla and chin.
- . Infant craniofacial surgery ( i.e. Craniosynostosis, Congenital malformations)
- . Le Forte ( I, II, III ) Osteotomies.
- . Pediatric Reconstructive procedures of Cranial facial Skeleton
- . Orthognathic or Reconstructive procedures of mid-face, maxilla & chin.
- Facial Craniotomy flap fixation. .
Device Description
Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable, Self Compression Bone Fixation plates, meshes, fixation screws, fasteners, tacks, tenion wires and anchor pins designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable, self compression, Bone fixation plates are offered in various sizes and configurations to meet anatomical needs of the patients. TheAdjustable Bone Plates™- Bioabsorbable Craniofacial Bone Fixation plates, mesh, screws .tension wires, tacks and anchor pins are made from bioabsorbable co-polymer material of Poly (L -Lactide & DL-Lactide-70:30 or 85:15 ). The bone plates and meshes are designed to be used with 1.8mm and 2.1 mm screws, tacks and anchor pins for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm conventional screw driver or deployed with endoscopic device.
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K Number
K071138Device Name
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
Manufacturer
PROSURG, INC.
Date Cleared
2007-08-15
(152 days)
Product Code
GXR, HBW
Regulation Number
882.5250Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy
Device Description
Not Found
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K Number
K070737Device Name
XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES
Manufacturer
PROSURG, INC.
Date Cleared
2007-07-25
(131 days)
Product Code
JEY
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
General Indication for Use: Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children. Specific Indications for Use: - Fractures of the cranium, mid-face, maxilla and chin. - Infant craniofacial surgery (i.e. Craniosynostosis, Congenital malformations) . - Le Forte ( I, II, III ) Osteotomies. . - Pediatric Reconstructive procedures of Cranial facial Skeleton . - Orthognathic or Reconstructive procedures of mid-face, maxilla & chin. ● - Facial Craniotomy flap fixation. ●
Device Description
Xsorb™ Bicabsorbable Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable Bone Fixation plates, meshes, fixation screws, fastners and tacks designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable Bone fixation plates and meshes are offered in various sizes and configurations to meet anatomical needs of the patients. The Xsorb™ - Bioabsorbable Craniofacial Bone Fixation pltaes & screws / wires are made from bioabsorbable co-polymer material of Poly (L -Lactide & DL-Lactide-70:30 or 85:15 ) . The bone plates and meshes are designed to be used with 1.8mm screws and 2.1 mm emergency screws for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm screw driver.
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K Number
K070846Device Name
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
Manufacturer
PROSURG, INC.
Date Cleared
2007-07-02
(96 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI ) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroenterological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.
Device Description
The MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Modular Anchor System is available with Single use, universal introducer device with notched tip design, compatible with Fixed, Adjustable and Snap-On modular self anchoring fixation ends of urethral sling and surgical mesh. The Introducer tip can be attached to slot in the fixation anchor for quick connect & disconnect for easy delivery of urethral sling and surgical mesh into target soft tissue. The position of Fixation anchors and sling can also be adjusted intra-operatively using introducer. The T anchors and Split anchors can be delivered in to soft tissue using, modified needle device with ease and minimum discomfort to the patient. The introducer device is available in straight, curved malleable and detachable configuration in various length and curvature to meet physician's preference, patient's anatomy & surgical procedure requirements.
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K Number
K060326Device Name
LASERTX - DIODE LASER & DELIVERY SYSTEM
Manufacturer
PROSURG, INC.
Date Cleared
2006-04-05
(55 days)
Product Code
GEX, OCL
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laser Ix Diode Laser System is intended for delivery of laser light to soft tissue in contact or non contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Laser Ix laser system is generally indicated for incision, excision Vaporization, ablation, hemostatis or coagulation of soft tissue In Ear, Nose and Throat and Oral surgery (Otolaryngology), Dental Procedures, Arthroscopy Gastroenterology, General Surgery, Dermatology Plastic surgery, Podiatry, Urology, Gynecology, Neurosurgery (Peripheral nervous system) Pulmonary surgery and cardiothoracic surgery. The Laser Tx Diode laser system can be used with fiber optic laser delivery devices and photosensitizing agents & chromophores to enhance target tissue effects and photo selective application during surgical procedures. The LaserTx Diode Laser system is indicated for incision, excision, vaporization, hemostatis coagulation, ablation of soft tissue, tumors, strictures, obstructions in body organs including urethra, bladder, prostate, uterus, breast, stomach, colon, abdomen, veins lung, brain, ear, nose throat etc. For additional indications for use please refer to attachment. (Additional Indications, identical to predicated device cleared by FDA under 510K application # K032864)
Device Description
LaserTx™ - Diode Laser & Delivery System
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K Number
K050488Device Name
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
Manufacturer
PROSURG, INC.
Date Cleared
2005-04-01
(35 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.
Device Description
TURBT- RF electrodes and Electrosurgical devices
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K Number
K042780Device Name
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
Manufacturer
PROSURG, INC.
Date Cleared
2005-02-03
(120 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neoscope™ - Endoscopic Diagnostic and Treatment System is intended for cystoscopic, hysteroscopic laparoscopic and endoscopic treatment of urological, gynecological, gasteroenterological disorders and diseases of prostate, bladder, urethra, uterine cavity, stomach, GI, urinary tract and reproductive organs using biomaterials, laser & RF devices, tissue ablative and augmenting agents, microsurgical instrument and endoscopic accessories.
Device Description
Not Found
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K Number
K030631Device Name
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
Manufacturer
PROSURG, INC.
Date Cleared
2003-05-19
(80 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PROSURG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zippere™ - Bioabsorbable / Non-absorbable Polymer Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the urological, gynecological or gastroentrological anatomy. This includes, but not limited to, the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolabse repair, reconstruction of the pelvic floor and secral colposuspension.
Device Description
Zippere™ - Bioabsorbable/Non-absorbable Polymer Sling and Surgical Mesh
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