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KNF — Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Class II

FDA Device Classification

Classification Details

Product Code
KNF
Device Class
Class II
Regulation Number
884.4160
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250705gynesonicsSonata Transcervical Fibroid Ablation System 2.2April 2, 2025
K240503gynesonicsSonata Transcervical Fibroid Ablation System 2.2July 17, 2024
K233848gynesonicsSonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)December 21, 2023
K222304gynesonicsSonata Transcervical Fibroid Ablation System 2.2November 8, 2022
K211535gynesonicsSonata Transcervical Fibroid Ablation System 2.2June 17, 2021
K193516gynesonicsSonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1May 4, 2020
K173703gynesonicsSonata Sonography-Guided Transcervical Fibroid Ablation SystemAugust 15, 2018
K132135lina medical apsLINA GOLD LOOP HCJanuary 31, 2014
K121343atc technologiesMODULAP LOOPJune 14, 2013
K103726integra lifesciences corporationJARIT TAKE-APART ENDOSCOPIC INSTRUMENTSFebruary 8, 2012
K092897medsysLAP LOOPFebruary 1, 2010
K070315lina medical apsLINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8October 30, 2007
K022979instruments medicaux g.bLAPARETTE, MODEL LAP J L S H NDecember 18, 2002
K010752aesculapAESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGYJune 11, 2001
K003405highland / mariettaENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEMay 7, 2001
K010425hdcEPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)March 15, 2001
K981463omnitech systemsOMNITECH RESECTOSCOPE ROLLER ELECTRODEJuly 17, 1998
K981464omnitech systemsOMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODEJuly 10, 1998
K970961richard wolf medical instrumentsVAPORIZATION ELECTRODESApril 10, 1998
K972856rocket medicalULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLSFebruary 11, 1998