FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K971621 |
AARON MEDICAL INDUSTRIES |
RESISTICK SOLID LAPAROSCOPIC ELECTRODES |
06/20/1997 |
K010752 |
AESCULAP, INC. |
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY |
06/11/2001 |
K121343 |
ATC TECHNOLOGIES, INC. |
MODULAP LOOP |
06/14/2013 |
K964594 |
CIRCON CORP. |
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) |
08/15/1997 |
K971838 |
COOPERSURGICAL, INC. |
MICRO ELECTRODES |
11/05/1997 |
K964441 |
GYNECARE INNOVATION CENTER |
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU |
03/28/1997 |
K193516 |
Gynesonics, Inc |
Sonata« Sonography-Guided Transcervical Fibroid Ablation System 2.1 |
05/04/2020 |
K173703 |
Gynesonics, Inc. |
Sonata Sonography-Guided Transcervical Fibroid Ablation System |
08/15/2018 |
K211535 |
Gynesonics, Inc. |
Sonata Transcervical Fibroid Ablation System 2.2 |
06/17/2021 |
K222304 |
Gynesonics, Inc. |
Sonata Transcervical Fibroid Ablation System 2.2 |
11/08/2022 |
K010425 |
HDC CORP. |
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) |
03/15/2001 |
K003405 |
HIGHLAND / MARIETTA, INC. |
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO |
05/07/2001 |
K022979 |
INSTRUMENTS MEDICAUX G.B., INC. |
LAPARETTE, MODEL LAP J L S H N |
12/18/2002 |
K103726 |
INTEGRA LIFESCIENCES CORPORATION |
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS |
02/08/2012 |
K132135 |
LINA MEDICAL APS |
LINA GOLD LOOP HC |
01/31/2014 |
K070315 |
LINA MEDICAL APS |
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 |
10/30/2007 |
K092897 |
MEDSYS, S.A. |
LAP LOOP |
02/01/2010 |
K981464 |
OMNITECH SYSTEMS, INC. |
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE |
07/10/1998 |
K981463 |
OMNITECH SYSTEMS, INC. |
OMNITECH RESECTOSCOPE ROLLER ELECTRODE |
07/17/1998 |
K971146 |
RD CHUS, INC. |
LAPARETTE |
08/25/1997 |
K970961 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
VAPORIZATION ELECTRODES |
04/10/1998 |
K972856 |
ROCKET MEDICAL PLC |
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS |
02/11/1998 |