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510(k) Data Aggregation
K Number
K102117Device Name
TISSU TRANS FILTRON SYRINGE FILL
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
2010-08-06
(9 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tissu Trans Filtron Syringe Fill is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
Tissu Trans Filtron Syringe Fill is used in the aspiration, harvesting, filtering and transferring of autologous tissue.
Tissue Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:
- Plastic and Reconstructive Surgery
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery
- Urological Surgery
- General Surgery
- Orthopedic Surgery
- Gynecological Surgery
- Thoracic Surgery
- Laparoscopic Surgery
Device Description
Shippert Medical's Tissu Trans Filtron Syringe Fill is an optional accessory to Shippert Medical's Tissu Trans Filtron, k092482. Shippert Medical's Tissu Trans Filtron Syringe Fill is a sterile, single use, disposable device used in the aspiration, harvest, filtering and transferring of autologous tissue. Used by physicians in the harvesting of body tissues, this device is a single use, disposable sterile canister with six enclosed 60cc syringes used for collecting the harvested tissue after harvesting/aspiration.. The harvested tissue is stored in the Syringe Fill syringes and is intended for immediate reinjection of the harvested tissue back into the donor patient.
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K Number
K092482Device Name
TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
2009-12-04
(113 days)
Product Code
MUU, KYZ
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
Tissu Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue,
Tissu Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:
- Plastic and Reconstructive Surgery
- Neurosurgery
- Gastrointestinal and Affiliated Organ surgery
- Urological Surgery
- Orthopedic surgery
- Gynecological Surgery
- Thoracic surgery
- Laparoscopic Surgery
Device Description
The Tissu Trans Filtron is provided in a sterile, two piece packaged assembly: The Tissu Trans Filtron. The Tissu Trans Filtron is a single-use, sterile, disposable device designed to utilize an FDA, cleared house vacuum to create suction within the physician supplied hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the autologous tissue into the collection canister.
The Tissu Trans Filtron is a sterile, single-use, manual device consisting of a medical grade polycarbonate canister, a medical grade polypropylene lid with various ports, medical grade silicone connection tubings for aspiration of waste, harvesting of tissue and transferring of filtered autologous tissue. A polypropylene clamp is included for clamping off the tubing as needed. A medical grade polyester mesh filter lining is contained within the canister.
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K Number
K092022Device Name
TISSU TRANS HARVEST TUBING
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
2009-08-17
(42 days)
Product Code
KYZ
Regulation Number
880.6960Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K050797Device Name
TISSU-TRANS
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
2005-07-13
(106 days)
Product Code
KYZ, REQ
Regulation Number
880.6960Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired.
Tissu-Trans™ is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.
Device Description
Tissue-Trans™ is a sterile, single use, disposable syringe device used in the harvesting, filtering and transferring of autologous fat. Used by acinso asounding procedures,Tissue Trans™ simplifies and reduces the steps prysiolane in the collection and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection.
Tissu-Trans™ is a piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small10cc syringe is placed inside a larger 60cc barrel type tube, which is attached to a medical grade tubing and aspiration machine. As the autologous fat is collected into the 10cc syringe, the waste products are strained through the holes in the 10cc syringe into the large 60cc barrel tube and suctioned into a waste container. The small syringe is removed from the large 60cc tube, a sleeve is attached to the small 10cc syringe around the barrel and the autologous fat is re-injected into the patient at desired locations.
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K Number
K964855Device Name
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
1997-03-04
(90 days)
Product Code
HOZ
Regulation Number
886.4790Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964334Device Name
EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
1996-12-09
(39 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that establishes this product line as safe and effective for use in surgery.
Device Description
The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that establishes this product line as safe and effective for use in surgery. There is no modification in the proposed device and the predicate devices that alters safety and effectiveness. The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate device stated.
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K Number
K963704Device Name
MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
1996-11-26
(71 days)
Product Code
LYG
Regulation Number
890.5660Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used in the treatment and management of muscle spasm and muscle tension.
Device Description
The proposed changes to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The modifications of design change of "S" shape, adding roller beads and handles, adding interchangeable massage balls and adding a collapsible feature does not change the safety or effectiveness of this device.
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K Number
K962133Device Name
EXPANDACELL INJECTO-PAK
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
1996-08-01
(59 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
administration of liquid medication and hydrating for the sinus
Device Description
Expandacell Injecto-Pak Foam Pack
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K Number
K960621Device Name
EXPANDACELL INSTRUMENT WIPE
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
1996-04-01
(48 days)
Product Code
GEC, GER
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.
Device Description
The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe.
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K Number
K960228Device Name
EXPANDACELL INJECTO-PAK NASAL PACK
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
1996-02-27
(41 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Applicant Name (Manufacturer) :
SHIPPERT MEDICAL TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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