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Found 7 results
510(k) Data Aggregation
K Number
K223689Device Name
Disposable Needle Guides and Grids
Manufacturer
Advance Medical Designs, Inc.
Date Cleared
2023-08-02
(236 days)
Product Code
ITX
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
Advance Medical Designs, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.
Device Description
Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
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K Number
K163050Device Name
Advance Medical Designs, Inc. Sterile Ultrasound Gel
Manufacturer
ADVANCE MEDICAL DESIGNS, INC.
Date Cleared
2017-10-25
(358 days)
Product Code
MUI
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
ADVANCE MEDICAL DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Advance Medical Designs, Inc. Sterile Ultrasound Gel is intended for general use as a sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's intact skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
Device Description
Advance Medical Designs, Inc. Sterile Ultrasound Gel consists of deionized water, glycerin, butylene glycol, glyceryl acrylic acid copolymer, propylene glycol, carbomer, phenoxyethanol, cellulose gum, sodium hydroxide, hydroxyethlcellulose, ethylhexylglycerin. It is a type of conductive medium (i.e.) scanning gel used in ultrasound therapeutic and diagnostic imaging techniques. A scanning gel acts as a couplant that provides an acoustic pathway between transducer and the intact skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts to the contours of the probe to the intact skin.
The major characteristics of Advance Medical Designs, Inc. Sterile Ultrasound Gel:
- Hypoallergenic, non-irritating
- Water soluble, non-staining and easily cleanable
- Free from formaldehyde and salt
- Does not contain oil or fatty matter
- No toxic effects
- Vacuum treated production
- Produced as a completely harmless material
- Does not damage the probe
- Does not contain air bubbles
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K Number
K053495Device Name
EQUIPMENT SLUSH DRAPE
Manufacturer
ADVANCE MEDICAL DESIGNS, INC.
Date Cleared
2006-03-16
(91 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
ADVANCE MEDICAL DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.
Device Description
The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use
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K Number
K011265Device Name
ULTRASOUND TRANSDUCER COVER
Manufacturer
ADVANCE MEDICAL DESIGNS, INC.
Date Cleared
2001-10-30
(188 days)
Product Code
ITX
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
ADVANCE MEDICAL DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K012168Device Name
ADVANCE MEDICAL DESIGNS FLUID POUCH
Manufacturer
ADVANCE MEDICAL DESIGNS, INC.
Date Cleared
2001-09-18
(68 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
ADVANCE MEDICAL DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advance Medical Designs Fluid Pouch is a body fluid drainage device. The Fluid Pouch is used for Hysteroscopy, Cystoscopy, Urology, and Brachytherapy procedures.
Device Description
Not Found
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K Number
K011422Device Name
SURGICAL DRAPES
Manufacturer
ADVANCE MEDICAL DESIGNS, INC.
Date Cleared
2001-07-10
(62 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
ADVANCE MEDICAL DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003670Device Name
PATIENT DRAPE, SURGICAL
Manufacturer
ADVANCE MEDICAL DESIGNS, INC.
Date Cleared
2001-01-26
(59 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
ADVANCE MEDICAL DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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