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Found 8 results
510(k) Data Aggregation
K Number
K091441Device Name
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
Manufacturer
SYNERGETICS, INC.
Date Cleared
2009-10-30
(168 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SYNERGETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.
Device Description
The Synergetics AGPI Tubing set is a PVC tubing set intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The tubing set consists of a three channel IV spike, for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to deliver air from an air supply unit through the solution; while the dual PVC tubing also administers humidified air (clear lumen) and saline (green stripe lumen); this dual PVC tubing has a three-way stopcock for proper connection.
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K Number
K063489Device Name
STRYKER INTRADISCAL RF GENERATOR
Manufacturer
SYNERGETICS, INC.
Date Cleared
2007-05-23
(187 days)
Product Code
GXD
Regulation Number
882.4400Why did this record match?
Applicant Name (Manufacturer) :
SYNERGETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath™ & Acutherm™ catheters.
Device Description
The Stryker Intradiscal RF Generator when used with the separately cleared Stryker RF Intradiscal Adapter and the separately cleared Smith & Nephew SPINECATH™ Intradiscal Catheter (K993967) ACUTHERM ™ Decompression Catheter is is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
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K Number
K032598Device Name
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
Manufacturer
SYNERGETICS, INC.
Date Cleared
2003-11-24
(91 days)
Product Code
MPA, GEX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SYNERGETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.
Device Description
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.
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K Number
K020220Device Name
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
Manufacturer
SYNERGETICS, INC.
Date Cleared
2002-08-23
(213 days)
Product Code
LFL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SYNERGETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synergetics Sonotome™ Ultrasonic Aspirator Tips are intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Thoracoscopic Surgery.
Device Description
Synergetics Sonotome™ Ultrasonic Aspirator Tips are accessories that are attached to the handpiece of an ultrasonic surgical aspirator system manufactured by another company. The tip, which simply transmits power from the system handpiece, is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissues while preserving vessels, ducts and other delicate structures. The main features on the Synergetics Sonotome™ Ultrasonic Aspirator Tips are: A variety of tip diameters, shapes and lengths are available for specific surgical applications. Curved tips are bent so as to provide clear visualization of the surgical site, unobstructed by the handpiece. Individually packaged, sterile tips can be replaced without the need for resterilization of the handpiece. Preaspiration holes in the tips minimize clogging and keep the tip clear of debris.
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K Number
K010637Device Name
SONOTOME ULTRASONIC ASPIRATOR TIPS
Manufacturer
SYNERGETICS, INC.
Date Cleared
2001-04-20
(46 days)
Product Code
LFL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SYNERGETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990568Device Name
SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01
Manufacturer
SYNERGETICS, INC.
Date Cleared
1999-05-14
(80 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SYNERGETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synergetics Inc., Mode Scrambled LindoOto Laser Probe provides a means of delivering photocoagulation during otologic surgery. Indications include, but are not limited to treatment of stapes related disorders to be treated with stapedectorny by means of photocoagulation. This device transmits laser energy to target tissuc, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissuc and the probe tip.
Device Description
Mode Scrambled EndoOto Laser Probe
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K Number
K982212Device Name
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
Manufacturer
SYNERGETICS, INC.
Date Cleared
1998-12-02
(162 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SYNERGETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures. It is designed for use with most available bipolar electrosurgical units, and will provide a means of transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis
Device Description
The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures.
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K Number
K964005Device Name
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
Manufacturer
SYNERGETICS, INC.
Date Cleared
1997-06-09
(275 days)
Product Code
MPA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SYNERGETICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synergetics Fiber Optic light Source is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.
Device Description
The Synergetics lightsource is a stand alone arc-lamp based lightsource that incorporates a standard connector mount used by most endoilluminators. It has a brightness control, accessory filter control and lamp life timer display.
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