FDA.reportPublic FDA data

510(k) K971146

Device
Laparette
Applicant
RD CHUS, INC.
510(k) number
K971146
Product code
KNF
Decision
Substantially Equivalent (SESE)
Decision date
1997-08-25
Date received
1997-03-28
Regulation
884.4160
Classification name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROSINA ROBINSON
Address
49 Plain St. North Attleboro MA US 02760 02760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.2018-08-15
K132135LINA GOLD LOOP HCLina Medical Aps2014-01-31
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K103726JARIT TAKE-APART ENDOSCOPIC INSTRUMENTSIntegra LifeSciences Corporation2012-02-08
K092897LAP LOOPMedsys, S.A.2010-02-01
K070315LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps2007-10-30
K022979LAPARETTE, MODEL LAP J L S H NInstruments Medicaux G.B., Inc.2002-12-18
K010752AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGYAesculap, Inc.2001-06-11
K003405ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPOHighland / Marietta, Inc.2001-05-07