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Found 5 results
510(k) Data Aggregation
K Number
K023372Device Name
NON-BIOABSORBABLE STAPLE
Manufacturer
ONUX MEDICAL, INC.
Date Cleared
2002-12-27
(80 days)
Product Code
NJU
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
ONUX MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coil Fixation Device is intended for fixation of prosthetic material and approximation of tissue in endoscopic and open surgical procedures.
Device Description
The subject device is designed to deliver fixation springs via a minimally invasive sterile disposable instrument that is for single patient use. The fixation springs are made of nitinol and are composed of 3 coils that are approximately .18 inches in diameter. The spring is held within the lumen of a needle is inserted through the tissue or prosthetic material to be approximated or fixated and the spring is pushed out so that approximately 1 coil of the spring is released. The needle is then withdrawn from the tissue or prosthetic material while the remainder of the spring is pushed out thereby deploying at least one coil on the proximal surface of the tissue or prosthetic material. Because the spring is manufactured such that the coils are naturally pre-compressed against each other, the distal and proximal coils place a compression force on the tissue or prosthetic material that holds them together.
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K Number
K022777Device Name
MANUAL TOUCHE SYSTEM
Manufacturer
ONUX MEDICAL, INC.
Date Cleared
2002-11-19
(90 days)
Product Code
GAQ, GAO, HCF
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
ONUX MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).
Device Description
A single-use, surgical instrument for placing stainless steel sutures.
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K Number
K014286Device Name
SALUTE, MODEL 3022
Manufacturer
ONUX MEDICAL, INC.
Date Cleared
2002-03-08
(71 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
ONUX MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Salute Fixation System is indicated for use in a variety of laparoscopic / endoscopic or open surgical procedures for fixation of prosthetic material and approximation of tissue.
Device Description
A minor modification has been made to the Salute staples in that a coating has been added to the surface of the staples. A reusable surgical instrument with integral disposable cartridge for placing coated stainless steel constructs. This instrument may be used laparoscopically with 5mm trocars.
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K Number
K010620Device Name
ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
Manufacturer
ONUX MEDICAL, INC.
Date Cleared
2001-05-17
(77 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ONUX MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Salute staple removal instrument is a re-useable instrument intended for laparoscopic or open removal of Salute staples.
Device Description
The subject device is a manual instrument for endoscopic or open surgical procedures. It employs a trigger handle design with an actuation lever and 5mm shaft. A rod at the end of the shaft engages the underside of the staple and pulls it inside the shaft when the lever is actuated. When the lever is released, the staple is release from within the device. The instrument is re-useable and is sterilized by steam autoclave.
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K Number
K003522Device Name
SALUTE
Manufacturer
ONUX MEDICAL, INC.
Date Cleared
2001-02-13
(90 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
ONUX MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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