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510(k) Data Aggregation
K Number
K121261Device Name
ASAP MUITISCOPE
Manufacturer
ASAP ENDOSCOPIC PRODUCTS GMBH
Date Cleared
2013-01-08
(257 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
ASAP ENDOSCOPIC PRODUCTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.
Device Description
The asap multiscope is a rigid or semiflex-type multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel and one or two irrigation channel(s) and stopcocks. The body consists of an outer and an inner tube of surgical steel. The light-carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod lens system, the working channel and the irrigation/suction channel(s). The eyepiece and light post are adaptable to standard endoscopic cameras and light systems. The endoscope is intended for use with standard working sheaths (cannulas) for minimally invasive access. Accessories include working sheaths, spinal needles, guide wire, dilators, trephine, hammers, trocars, forceps, and rongeurs, as well as cleaning brushes, a rubber sealing cap, spare O-rings, and a protection sheath.
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K Number
K032822Device Name
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
Manufacturer
ASAP ENDOSCOPIC PRODUCTS GMBH
Date Cleared
2004-01-08
(120 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
ASAP ENDOSCOPIC PRODUCTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.
The asap ENT endoscope is reusable.
Device Description
The asap ENT endoscope is of the rigid type with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap ENT endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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K Number
K031974Device Name
ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
Manufacturer
ASAP ENDOSCOPIC PRODUCTS GMBH
Date Cleared
2003-09-29
(95 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
ASAP ENDOSCOPIC PRODUCTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hysteroscope: Provides illumination and visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Gynecologic Laparoscope: Used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Device Description
The asap hysteroscope and gynecologic laparoscope (herinafter: asap endoscope) is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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K Number
K031972Device Name
ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
Manufacturer
ASAP ENDOSCOPIC PRODUCTS GMBH
Date Cleared
2003-09-15
(81 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
ASAP ENDOSCOPIC PRODUCTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrlst (carpal tunnel syndrome), temporal-mandibular joint, ankle and elbow.
The asap arthroscope is reusable and has to be sterilized prior to each procedure by the user.
The intended use for the asap arthroscope is according to relevant medical indication by trained physicians only.
Device Description
The asap arthroscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap arthroscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light quide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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K Number
K031141Device Name
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE
Manufacturer
ASAP ENDOSCOPIC PRODUCTS GMBH
Date Cleared
2003-06-30
(81 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ASAP ENDOSCOPIC PRODUCTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
Device Description
The asap endoscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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