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510(k) Data Aggregation
K Number
K012033Device Name
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
Manufacturer
Date Cleared
2001-09-20
(83 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SEEDLING ENTERPRISES. LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MEI is a laparoscopic and endoscopic, bipolar, electrosurgical device intended for grasping, dissecting, coagulating and transecting tissue in laparoscopic and open procedures.
The types of surgery indicated are:
General surgery Laparoscopic procedures Endoscopic procedures Laryngeal coagulation Orthopedic coagulation Thorascopic coagulation Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization) Ear, Nose and Throat coagulation
Device Description
The Multifunction Endoscopic Instrument is a single patient use device, which is a combination scissors and bipolar coagulator-grasper. It is intended for use in canjunction with presently employed 5-10mm trocar cannulae. The instrument grasping and cutting functions are operated easily using one hand. The device is indicated for use in a variety of open and minimally invasive procedures. It is designed to facilitate grasping, mobilization, dissection, coagulation and transection of tissue.
The grasping and cutting functions of the distal end are accomplished by employing three elements.
- A central stationary member serves as both a scissors blade and a forceps jaw.
- A separate scissors blade and a forceps jaw are attached to the some that they can be independently pivoted to open and close thereby performing the cutting and grasping functions.
- The pivoting scissors blade and forceps jaw are connected to the handle and actuated via linkages.
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K Number
K010710Device Name
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
Manufacturer
Date Cleared
2001-05-18
(70 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SEEDLING ENTERPRISES. LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K002841Device Name
COOL-TEC ELECTRODES
Manufacturer
Date Cleared
2000-12-08
(87 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SEEDLING ENTERPRISES. LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001723Device Name
COOL-TEC ELECTRODES
Manufacturer
Date Cleared
2000-07-19
(43 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SEEDLING ENTERPRISES. LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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