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510(k) Data Aggregation
K Number
K170285Device Name
AED Sinuscope
Manufacturer
National Advanced Endoscopy Devices, Inc.
Date Cleared
2017-08-01
(183 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
National Advanced Endoscopy Devices, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AED Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
Device Description
The AED Sinuscope is a reusable rod lens sinuscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem.
AED Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view).
The AED Sinuscope is reusable and provided non-sterile. It must be cleaned and sterilized prior to use.
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K Number
K141515Device Name
AED HYSTEROSCOPE AND ACCESSORIES
Manufacturer
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Date Cleared
2015-01-07
(212 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AED Hysteroscope and Accessories are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Device Description
The AED Hysteroscope and Accessories is a reusable surgical device that incorporate operative and examination sheaths. The AED Hysteroscope is a reusable rod lens Hysteroscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem. Examination Sheaths are designed to be used with a hysteroscope alone. An operative sheath is an examination sheath with one or more instrument channels. The operative and examination sheaths are composed of surgical grade stainless steel with the exception of a Fixing Ring (where applicable) which is composed of Nylon. There are two designs for Continuous Flow Sheaths. One design consists of a single sheath with two interior channels (18-2307 and 18-2308) for the inflow and outflow of media to be used with the hysteroscope alone. Alternatively, an inner and outer sheath may be used to perform the same function (18-2304 and 18-2309). The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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K Number
K102663Device Name
AED RESECTOSCOPE
Manufacturer
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Date Cleared
2010-12-30
(106 days)
Product Code
FJL, FAS, FDC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.
Device Description
Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of:
- · Endoscope
- · Resectoscope sheaths with obturators
- · Working Element
- · Electrodes
The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use.
The body contact materials are surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
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K Number
K081553Device Name
AED BIPOLAR FORCEPS, MODEL 13-1646
Manufacturer
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Date Cleared
2008-09-29
(118 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AED Bipolar Forceps are reusable devices (bipolar forceps/scissors and electrodes) that facilitate grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current (bipolar electrocautery). AED Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal ligation/coagulation for sterilization procedures. Do not use these bipolar forceps for these procedures.
Device Description
AED Bipolar Forceps consist of
• Standard insulated bipolar handles
• Outer shaft with insulated tip
• Jaw inserts (forceps, scissors)
The device is reusable and provided non-sterile. The device must be cleaned and sterilized before use. All forceps are of the same basic design with differences in tip configurations.
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K Number
K081503Device Name
AED MONOPOLAR LAP ACCESSORIES
Manufacturer
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Date Cleared
2008-09-25
(119 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AED Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
Device Description
AED Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated Shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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K Number
K993689Device Name
AED CYSTOSCOPE
Manufacturer
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Date Cleared
1999-12-15
(44 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used to provide visual information about the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure.
The AED line of rigid Cystoscopes is indicated to provide illumination and visualization in:
- Diagnostic cystoscopy procedures.
Device Description
AED Cystoscope
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K Number
K993688Device Name
AED LAPAROSCOPE
Manufacturer
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Date Cleared
1999-12-06
(35 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used to provide visual information about the condition of the interior of the pelvic cavity, and visualization of the interior of the abdominal cavity or areas subject to general or plastic surgery for diagnostic and surgical procedures. This device provides information for diagnosis and/or surgical access with only a small incision.
The AED line of rigid Laparoscopes is indicated to provide illumination and visualization in:
- Diagnostic and operative laparoscopic procedures.
Device Description
AED Laparoscope
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K Number
K991656Device Name
AED ARTHROSCOPE
Manufacturer
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Date Cleared
1999-12-02
(203 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in: Diagnostic and operative arthroscope procedures.
Device Description
Not Found
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