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Found 6 results
510(k) Data Aggregation
K Number
K092421Device Name
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
Manufacturer
GIMMI GMBH
Date Cleared
2010-02-12
(189 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
GIMMI GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
Device Description
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures. The use of AlphaScope Hysteroscope is restricted for the use of endoscopic surgeons and qualified assistants. AlphaScope Hysteroscopes are re-useable, they can be sterilized by 134 C Degrees Steam Autoclave.
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K Number
K093125Device Name
ALPHAXENON LIGHT 180 W AND 300 W
Manufacturer
GIMMI GMBH
Date Cleared
2010-01-27
(117 days)
Product Code
GCT
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
GIMMI GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.
Device Description
AlphaXenon Light is a light generating device that when used with in conjunction with endoscopes to illuminate surgical site during Endoscopic procedures.
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K Number
K081640Device Name
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
Manufacturer
GIMMI GMBH
Date Cleared
2009-05-06
(329 days)
Product Code
HCH
Regulation Number
882.5200Why did this record match?
Applicant Name (Manufacturer) :
GIMMI GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for Permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary permianent occlusion of blood vessel clips are intended for temporary occlusion Gilvilli Aneurysin Olips (Tabargi) and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.
Device Description
GIMMI Aneurysm Clips and their Clip Applying Forceps are used for the occlusion of aneurysms. "Mini" and "Standard" Clips can only be applied with the according Applying forceps; these forceps are labelled with "Mini" or "Standard". Clips are available in different sizes and shapes, to have the right size and shape due to the size and shape of the aneurysm.
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K Number
K012869Device Name
GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
Manufacturer
GIMMI GMBH
Date Cleared
2002-03-11
(196 days)
Product Code
HIH, HDC, HET, HHO, KNA
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
GIMMI GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GIMMI ALPHA® Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.
Device Description
GIMMI ALPHA Hysteroscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of 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.
Laparoscopic and obstetric-gynecologic accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Some specialized instruments, such as the gynecologic fibroid screw and uterine tenaculum are one-piece.
The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).
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K Number
K012660Device Name
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
Manufacturer
GIMMI GMBH
Date Cleared
2001-12-20
(129 days)
Product Code
FET, EZO, FAJ, FAS, FBK, FBM, FCL, FDC, FDE, FED, FGC, FHA, FJL, GBZ, GCJ, GCT, GEI, KNS, KOA, KOD, KOE, KQT, LQR
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
GIMMI GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.
Device Description
GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of 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.
Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).
Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures
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K Number
K013731Device Name
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
Manufacturer
GIMMI GMBH
Date Cleared
2001-11-27
(18 days)
Product Code
EOQ, EOB
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
GIMMI GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GIMMI ALPHA Sinuscopes and Bronchoscopes are intended for use by qualified physicians to perform endoscopic diagnostic and therapeutic surgical procedures of the sinus and larynx/tracheobronchial tree respectively.
GIMMI ALPHA® Bronchoscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic surgical procedures of the larynx and tracheobronchial tree.
GIMMI ALPHA® Sinuscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic sinus surgical procedures.
Device Description
GIMMI ALPHA Sinuscopes and Bronchoscopes are reusable, hand-held instruments designed for performing diagnostic and therapeutic sinus and bronchial procedures. The devices have the same operating principles and intended uses as many of the competitive sinuscopes and bronchoscopes already in commercial distribution.
The devices are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of 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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