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Found 4 results
510(k) Data Aggregation
K Number
K121343Device Name
MODULAP LOOP
Manufacturer
ATC TECHNOLOGIES, INC.
Date Cleared
2013-06-14
(406 days)
Product Code
KNF
Regulation Number
884.4160Why did this record match?
Applicant Name (Manufacturer) :
ATC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modulap Loop is intended for monopolar electrosurgical coagulation/cutting during laparoscopic surgery. It is indicated for the amputation of the uterus during supracervical hysterectomy and for resection of pedunculated subserosal (abdominal) myomas.
It is not intended for use in hysteroscopy or for contraceptive coagulation of the fallopian tubes.
Device Description
The Modulap Loop is a 5 mm laparoscopic instrument. It consists of a standard insulated monopolar electrosurgical probe, with a flexible wire loop as its distal tip, and a sliding sheath constructed of insulating material. The wire loop is insulated except for a central approximately 1 inch cutting area. The device is a single-use sterile, disposable device. It is compatible with standard electrosurgical generators, and associated cables.
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K Number
K010473Device Name
SPARROWHAWK DISPOSABLE
Manufacturer
ATC TECHNOLOGIES, INC.
Date Cleared
2001-06-06
(106 days)
Product Code
DWZ
Regulation Number
870.4075Why did this record match?
Applicant Name (Manufacturer) :
ATC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994319Device Name
MODULAP
Manufacturer
ATC TECHNOLOGIES, INC.
Date Cleared
2000-03-20
(89 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ATC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic surgical procedures, (e.q. laparoscopic cholecystectorny, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube.
The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.
Device Description
When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, electrosurgical generator and suction/irrigation trumpet valve, the Candidate Devices provide irrigation, suction and electrosurgical cutting and coagulation capabilities to the operative site during general laparoscopic surgical procedures.
Provides electrosurgical cutting and coagulation to the surgical site during general laparoscopic surgical procedures by communicating the high-frequency electric current generated by a legally-marketed electrosurgical generator to the operative site.
The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.
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K Number
K983623Device Name
MODULAP
Manufacturer
ATC TECHNOLOGIES, INC.
Date Cleared
1998-12-18
(64 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ATC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic procedures, (e.g. laparoscopic cholecystectomy, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube.
The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.
Device Description
The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.
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