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Found 8 results
510(k) Data Aggregation
K Number
K002269Device Name
ELECTROSURGICAL PROBES AND DEVICES-GELTX
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
2001-01-04
(162 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
XIMED/PROSURE/INJECTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994151Device Name
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
2000-03-01
(83 days)
Product Code
GAA
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
XIMED/PROSURE/INJECTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PercuTx - Injection /Aspiration Needle device is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.
As with currently marketed endoscopic injection needles, the PercuTx Endoscopic Injection needle device may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic, and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic.
Device Description
PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece
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K Number
K983200Device Name
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
1998-12-11
(88 days)
Product Code
GAA
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
XIMED/PROSURE/INJECTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not intended for injection of drugs.
Device Description
Injection/Aspiration Needles Probes/Devices
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K Number
K983765Device Name
INJECTION NEEDLE PROBE/DEVICE-TUNIS
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
1998-12-11
(46 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
XIMED/PROSURE/INJECTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TUNIS™ probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection procedures. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary tract.
Device Description
TUNIS™ - Transurethral Injection System Probe/Device
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K Number
K981256Device Name
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
1998-05-12
(40 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
XIMED/PROSURE/INJECTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
electrosurgical probes and devices are to be used with The commercially available R.F. generators, endoscopes including laparoscopes, hysteroscopes, resectoscopes, cystoscopes and suction/irrigation systems. These devices can be used for lappeoscopic. hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.
Device Description
Isolated Electrosurgical Probes & Devices-Salinetrode™M (cutting loops, roller balls, roller bars/barrels, and needles/blades)
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K Number
K974484Device Name
ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
1998-02-10
(76 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
XIMED/PROSURE/INJECTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The electrosurgical probes and devices are to be used with commercially availbale R.F. Generators, endoscopes, and suction/irrigation sytems. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.
Device Description
Isolated Electrosurgical Probe/Device-Salinetrode
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K Number
K974637Device Name
ELECTRODES/PROBES/DEVICES
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
1998-01-07
(26 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
XIMED/PROSURE/INJECTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The electrosurgical probes and devices are to be used with commercially available R.F. generators, endoscopes including hysteroscopes, resectoscopes, cystoscopes and laparoscopes, suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.
Device Description
Electrodes/Probes/Devices
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K Number
K962593Device Name
ELECTROSURGICAL PROBES & DEVICES
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
1996-11-12
(133 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
XIMED/PROSURE/INJECTX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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