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510(k) Data Aggregation
K Number
K162588Device Name
Möller Medical Biopsy Needles and Systems
Manufacturer
Moller Medical GmbH
Date Cleared
2017-06-19
(276 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Moller Medical GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Möller Medical Biopsy Needles and Systems are used to obtain core samples and aspiration from tissue by biopsy. The various wall thicknesses, diameters, tip geometries and cutting techniques of the different hollow needle types and biopsy systems affect the quality of the biopsy specimen.
Model BOW-1060 bone marrow biopsy systems are intended for the atraumatic taking of specimens from and inside bones. Application areas of the products are bone respectively bone marrow.
Model BOW-1070 bone marrow aspiration biopsy set is intended for aspiration in the area of the sternum or iliac crest. Application areas of the products are bone respectively bone marrow.
Model BOY-1080 bone biopsy needle set has been designed for atraumatic bone biopsy. Application areas of the products are bone respectively bone marrow.
Model DNG-10XX single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions and are combined with biopsy guns.
Model full-sCore® DNG-2020 disposable biopsy needles are intended only for biopsies on soft tissue and tissue from soft, internal organs such as liver, kidney, breast, lung and various soft tissue lesions , and should be used with the Möller Medical Blue (RBG-1000-10-1000) biopsy gun.
Model FNB and MBY single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue for example from pleura cavity and associated organs, abdominal cavity and associated organs like breast, liver, prostate and kidney.
Model COX is for safe needle guidance and for taking several biopsy specimens. for example from liver, kidney, breast. thyroid, pancreas, spleen, lung and various soft tissue lesions, with only one single puncture.
Model ABG disposable automatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.
Model SBG disposable semiautomatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.
Model Möller Medical Blue RBG is a reusable, automatic biopsy gun that is intended exclusively for use with DNG-1020 / full-sCore® DNG-2020 disposable needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.
When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.
Device Description
The Möller Medical Biopsy Needles and Systems consist of Bone and Bone Marrow Aspiration Needles, Fine Needles, Disposable Needles for Biopsy Guns, Coaxial Needles, Manual Cut Biopsy Needles, Semi-automatic and automatic Biopsy Guns.
The Möller Medical Blue RBG is a re-usable biopsy gun to be used with corresponding needles to obtain core samples from soft tissue. It is a re-usable device, which has to be reprocessed. The biopsy needles used with this device are disposable products. The Möller Medical Blue RBG is intended to be used with the DNG-1020 and the DNG-2020 needles.
Bone Marrow Biopsy System (BOW-1060), Bone Marrow Aspiration Biopsy (BOW-1070) and Bone Biopsy Needles (BOY-1080) are for harvesting bone and bone marrow specimens manually or by aspirating with a syringe.
Fine Needle Biopsy (FNB-xxxx) is used for percutaneous withdrawal of mainly cytological evidence of soft tissue using a syringe attached to a Luer-Lock adapter.
Disposable Needles for Biopsy Gun (DNG-1010, -1020, -1030, -1040) are used for obtaining core biopsies of various tissues in combination with different automatic biopsy guns and can be used with a corresponding coaxial needle for multiple sampling.
Full-sCore® Biopsy Needle (DNG-2020) is used for biopsies of soft tissue in combination with the Möller Medical Blue. It has a double-lumen cannula tube with a bevelled edge tip cut, a trokar stylet, and a lengthwise spade for cutting tissue. It can be used with a corresponding coaxial needle for multiple sampling.
Semi-automatic Biopsy Gun (SBG-xxx) is a disposable device to obtain histological core samples from soft tissue. It is composed of a spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. It can be used with a corresponding coaxial needle for multiple sampling.
Automatic Biopsy Gun (ABG-xxxx) is a disposable device to obtain core samples for histological evidence from soft tissue. It can be used with a corresponding coaxial needle for multiple sampling.
Coaxial Needles (COX-xxx) are guiding needles used with biopsy needles or systems to take several biopsy specimens from the same target area with only a single puncture. The guiding needle has a larger total diameter and is shorter in length than the corresponding biopsy needle or system.
Manual Cut Biopsy (MBY-xxxx) is a manual biopsy needle for obtaining histological tissue specimens using the tru-cut technique.
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K Number
K150898Device Name
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
Manufacturer
MOLLER MEDICAL GMBH
Date Cleared
2015-12-18
(260 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
MOLLER MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiquoGuard 7 is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intrathecal pressure. The LiquoGuard 7 controls CSF pressure using pressure sensors and a pump and also monitors CSF pressure and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions.
Device Description
The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable drainage tube set, including two pressure sensors. The dynamic range of this system is from -75 mmHg to +100 mmHg. The drainage tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via a 3way stopcock and the LiquoGuard 7 device via cable connector. The device continuously measures the pressure of CSF due to the fluid column inside the tube and operates the peristalticpump of LiguoGuard 7 whenever the current patient's CSF pressure is higher than a preselected target pressure. Thus the LiguoGuard 7 combines CSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient's mobility.
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K Number
K121248Device Name
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
Manufacturer
MOLLER MEDICAL GMBH
Date Cleared
2013-12-13
(597 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
MOLLER MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiquoGuard CSF system is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF dripping chamber and collection bag (predicate devices). The LiquoGuard CSF system also monitors intracranial pressure up to 75 mmHg and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions not offered by the passive dripping chamber systems.
Device Description
The LiquoGuard CSF System consists of a pump and a corresponding tube set with pressure sensors. The dynamic range of this system is from -15mmHg to +75 mmHg. The tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via Luer-Lock and the LiquoGuard CSF System device via cable connector. The device then continuously measures the pressure inside the tube and operates a tube pump whenever the actual pressure is higher than a preselected target pressure. Thus the LiquoGuard CSF System combines CSF drainage and intracranial pressure (ICP) monitoring with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient mobility (by its battery back-up).
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