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510(k) Data Aggregation
K Number
K093511Device Name
SORING MBC200/BCC140
Manufacturer
SORING GMBH MEDIZINTECHNIK
Date Cleared
2010-04-16
(154 days)
Product Code
GEI, REG
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SORING GMBH MEDIZINTECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Soring MBC200/BCC140 devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures. Typical users of this system are trained medical professionals.
Device Description
Soring MBC200/BCC140 device has 2 configurations. Depending on the unit variant, the user can choose from the following functions:
- . MBC200: Monopolar cutting and Coaqulation and Bipolar Coagulation
- . BCC140: Bipolar Cutting and Coagulation
Electrosurgical devices are frequently used during surgical operations helping to prevent blood loss in hospital operating rooms or in outpatient procedures. Electrosurgery is performed using an Electrosurgical Generator (also referred to as Power Supply or Waveform Generator) and a handpiece including one or several electrodes, sometimes referred to as an RF Knife. Lower RF-voltages (below 150) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coaqulation. During the use of the Soring MBC200/BCC140 device, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts.
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K Number
K052183Device Name
SORING GMBH SONOCA LIPO
Manufacturer
SORING GMBH MEDIZINTECHNIK
Date Cleared
2005-10-07
(58 days)
Product Code
QPB, MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
SORING GMBH MEDIZINTECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SONOCA Lipo is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring.
Device Description
SONOCA Lipo™ is a modified version of the SONOCA 300 cleared by FDA under K992026 and can be used in two ways:
1. As an ultrasonic dissector / aspirator as in the SONOCA 300 to cut, irrigate, and suction at the surgical site and
2. As an alternative to conventional Lipectomy because it is a combination of a standard Lipectomy suction device and an Ultrasound assisted Lipectomy for the selective dissection of human fatty tissue.
The SONOCA Lipo™ can be trolley mounted or a desktop unit consisting of an ultrasonic generator, an infiltration pump and an aspiration pump. The nodular build of the electronic components allow the unit to function at a high capacity, totally free of electronic maintenance.
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K Number
K030028Device Name
CPC BY SORING GMBH
Manufacturer
SORING GMBH MEDIZINTECHNIK
Date Cleared
2003-01-17
(14 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SORING GMBH MEDIZINTECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are intended to cut and or coagulate soft biological tissue with gas-enhanced coagulation during general surgical procedures.
Device Description
During the use of RF surgery devices, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts. Lower RF-voltages (below 150veff) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coagulation.
Cold plasma technology using Helium gas is a very gentle method for coagulating or dissecting specific types of tissue. In contrast to conventional RF surgery, the penetration depth related to tissue damage and the electrical strain on the patient are significantly reduced (no electrical current flowing through the patient). The significantly lower peak current value (as compared to conventional spray coagulation) results in far less damage to tissue lavers immediately beneath the treatment area because constant sine-shaped currents are used.
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K Number
K024059Device Name
MBC SERIES
Manufacturer
SORING GMBH MEDIZINTECHNIK
Date Cleared
2003-01-08
(30 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SORING GMBH MEDIZINTECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures.
Device Description
The Soring GmbH MBC™ Series is a monopolar and bi-polar RF surgical device for cutting and coagulation. RF Surgery is the use of high frequency alternating electrical current (frequency higher then 300 kHz) with the purpose of alteration or destruction of cells and for cutting tissue. The Soring GmbH MBC™ Series is used for tissue removal and cauterization in connection with mechanical operation techniques. The tissue cauterization and cutting effects are accomplished by a combination of heating through the electrical resistance offered by the biological tissue and through the heating of the electrode. Heat production is mainly a result of the fact that biological tissue acts as an electrical resistor for frequencies normally used during RF surgery and that as an electrical resistor biological tissue heats up when electric currents flow through. The amount of heat developed is therefore dependent on the current and the resistance of the conductor (the biological tissue) put up by the patient. From an electrical point of view, the patient is the conductor. As a result, in a closed current loop of metallic conductors and biological tissue of equal cross sectional area the biological tissue heats up significantly more. As can be seen in the table below, different biological tissue types offer a wide range of electrical resistance and thus are affected differently by the applied RF signal. The Soring GmbH MBC™ Series internal circuitry automatically senses the resistivity and adjusts the RF signal accordingly for the best results.
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K Number
K012753Device Name
SORING GMBH SONOCA 180/190
Manufacturer
SORING GMBH MEDIZINTECHNIK
Date Cleared
2001-11-13
(89 days)
Product Code
LFL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SORING GMBH MEDIZINTECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SONOCA 180/190 is an instrument intended for selected ultrasound dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.
Device Description
SONOCA 180 & 190 is a desktop unit that controls ultrasonic handpieces used in general surgery, vascular surgery, and dermatological surgery.
general bargery, vacual carget case; technologically derived from the Sonoca 300 family of units (K992026) with the same general modules (hardware and software).
During the use of this ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue and is a supplementary tool for the selective dissection of human tissue.
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K Number
K993265Device Name
SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600
Manufacturer
SORING GMBH MEDIZINTECHNIK
Date Cleared
1999-10-22
(23 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SORING GMBH MEDIZINTECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are intended to cut and or coagulate (soft) biological tissue with gas enhanced coagulation in ARCO models, e.g. during general surgical procedures.
Device Description
ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 are an upgraded version of the ARCO MBC, ARCO MC, MBC 500 as described in K954171.
During the use of RF surgery devices, power is transmitted via an electrode in the contact zone to tissue. The active electrode then cuts or coagulates (depending upon its design and adjusted power form) the tissue. The inert gas coagulation uses an ionized beam of an inert gas (argon) to transmit the electrical energy to the tissue to achieve a coagulation effect.
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K Number
K992026Device Name
SORING GMBH, SONOCA 300
Manufacturer
SORING GMBH MEDIZINTECHNIK
Date Cleared
1999-09-23
(99 days)
Product Code
BTA, LFL
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
SORING GMBH MEDIZINTECHNIK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.
Device Description
SONOCA 300 is an upgraded version of the SONOCA III having K9942095.
During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.
The SONOCA 300 is not an alternative to conventional surgery but a supplementary tool for the selective dissection of human tissue.
Where as the scalpel and other methods of cutting are basically limited to cutting tissue. The SONOCA 300 can be used to cut, irrigate, and suction at the surgical site.
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