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Found 14 results
510(k) Data Aggregation
K Number
K033578Device Name
REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2005-07-11
(606 days)
Product Code
NLL
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reloadable Cutters
The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery.
Reloadable Staplers
The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.
Device Description
The Reprocessed Reloadable Cutters deliver two double-staggered rows of titanium staples while dividing the tissue between the rows. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.
The Reprocessed Reloadable Staplers deliver two double-staggered rows of titanium staples to approximate internal tissues. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.
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K Number
K033579Device Name
REPROCESSED MULTIPLE CLIP APPLIERS
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2005-07-11
(606 days)
Product Code
NMJ
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed multiple clip appliers are intended for the ligation of vessels or other tubular structures.
Device Description
The reprocessed multiple clip applier is an automatic ligating clip applier. The device is preloaded with a minimum of 10 titanium ligating clips that individually advance after each clip application.
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K Number
K033591Device Name
REPROCESSED TROCARS
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2005-06-03
(568 days)
Product Code
KBG
Regulation Number
874.4420Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.
Device Description
Reprocessed endoscopic trocars consist of an obturator and sleeve. The trocar sleeve has a stopcock valve for gas insufflation and a desufflation lever for gas evacuation. The trocar obturator are either flat bladed, pyramidal, or blunt tip. Bladed and dilating tip obturators have a safety shield that exposes the blade during insertion and retract over the tip after the operative cavity has been penetrated.
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K Number
K033592Device Name
REPROCESSED SURGICAL SCISSORS AND GRASPERS
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2004-07-27
(257 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearMedical Reprocessed Used, Disposable Endoscopic Scissors and Graspers have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue.
Device Description
The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic Scissors and Graspers) is a sterilized SUD. The reprocessed Endopath endoscopic instruments are sterile, single patient use instruments that have a rotating insulated shaft and are designed for use through appropriate surgical trocars. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Some instruments have a monopolar cautery connector extending from the top of the handle and can be used for electosurgery when properly attached to standard cautery cables and appropriate generators. Other instruments have rachet handles, which allow the instrument jaws to be locked in place. The instrument jaws or scissor blades are activated by compression and release of the ring handles. See instructions for complete mode of operation details. The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic details. The Reprosesses Coasted using EtO sterilization.
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K Number
K033593Device Name
REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2003-11-20
(7 days)
Product Code
NLU
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps are intended to be used during GI procedures for endoscopic tissue sample acquisition.
Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract.
Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.
Device Description
Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by Clear Medical to Clear Medical protocol Number 40003. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. Clear Medical is a "third party reprocessor" and reprocesses used, single-use medical devices. Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps. CMI intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive. CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical, Inc.
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K Number
K031416Device Name
CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2003-07-15
(71 days)
Product Code
DXQ
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement The ClearMedical Blood Pressure Cuff is intended as a single patient use item.
Device Description
Not Found
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K Number
K012600Device Name
CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2002-07-03
(324 days)
Product Code
NLF
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The adult Oxisensor, model D-25 and D-25L, is indicated for single patient use when continuous noninvasive artertal oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg.
The reprocessed ClearMedical/Nellcor D-25/ D-25L Oxisensor is intended as a single patient use transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor is the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of adult patients. The D-25/D-25L oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
Device Description
The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisens of the a the a transmission of functional oxygen saturation and and from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.
The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
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K Number
K012609Device Name
CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2002-07-03
(324 days)
Product Code
NLF
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The neonatal/adult Oxisensor, model N-25, is Indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing less than 3 kg or more than 40 kg.
The reprocessed ClearMedical/Nellcor N-25 Oxisensor is intended as a single patient use O₂ transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of neonatal and adult patients. The N-25 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
Device Description
The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.
The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
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K Number
K012622Device Name
CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2002-07-03
(324 days)
Product Code
NLF
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.
The reprocessed ClearMedical/Nellcor D-20 Oxisensor is intended as a single patient use O transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of pediatric patients. The D-20 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
Device Description
The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturering and pulse rate. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.
The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LED's and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
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K Number
K012601Device Name
CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2002-02-06
(177 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
CLEAR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.
Device Description
The ClearMedical/Aircast VenaFlow Cuffs are an accessory device to a VenaFlow System which is used for the prevention of deep vein thrombosis. The VenaFlow Cuff is designed with two inflatable bladders that fill with air to provide compression to the legs and feet. A connector tubing system attaches the Cuff to the pump system. The VenaFlow Cuffs are latex-free, made of a polyester-cotton fabric. They are The vehal low Oulls are latest nos, a proximal and distal bladder and polyethylene tubing with polypropylene luer-lock connectors.
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