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510(k) Data Aggregation
K Number
K092897Device Name
LAP LOOP
Manufacturer
MEDSYS, S.A.
Date Cleared
2010-02-01
(133 days)
Product Code
KNF
Regulation Number
884.4160Why did this record match?
Applicant Name (Manufacturer) :
MEDSYS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062968Device Name
LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES
Manufacturer
MEDSYS, S.A.
Date Cleared
2007-01-03
(96 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDSYS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LapMan can be used during the laparoscopic procedures listed below and should not be used for any other surgical procedure or purpose.
1. General surgery: laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding.
2. Gynaecology: laparoscopic adnexal surgery (ovarian cystectomy, oophorectomy, adnexectomy, salpingectomy, salpingoneostomy, tubal reanastomosis), laparoscopic management of ectopic pregnancy. laparoscopic treatment of endometriosis, laparoscopic myomectomy, laparoscopic hysterectomy, laparoscopic colposuspension
3. Urology: laparoscopic prostatectomy.
Device Description
LapMan is a robotic computer-driven system used by surgeon to hold and position a rigid laparoscope/endoscope. Surgeon orders are transmitted to the robotic system by a radiofrequency Hand Controlled device.
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K Number
K023735Device Name
LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001
Manufacturer
MEDSYS, S.A.
Date Cleared
2003-08-07
(273 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDSYS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LapMan Laparoscope Manipulator System and Accessories is indicated for use in General Surgery, Gynecology, and Urology where a laparoscope/endoscope is incorporated into the surgical procedure. The LapMan is indicated for specific laparoscopic surgical procedures as defined in the Operations Manual and should not be used for any other surgical procedure or purpose.
Device Description
LapMan is a robotic computer-driven system used by surgeon to hold and position a rigid laparoscope/endoscope. Surgeon orders are transmitted to the robotic system by a radiofrequency Hand Controlled device. It is indicated for use in General surgery (laparoscopic cholecystectomy, laparoscopic Nissen Fundoplication, laparoscopic inguinal hernia repair, laparoscopic gastric banding), Gynaecology (laparoscopic adnexal surgery i.e. ovarian cystectomy, oophorectomy, salpingectomy, salpingoneostomy, tubal reanastomosis, laparoscopic management of ectopic pregnancy, laparoscopic treatment of endometriosis, laparoscopic myomectomy, laparoscopic hysterectomy, laparoscopic colposuspension) and Urology (laparoscopic prostatectomy).
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