Panels › Gastroenterology, Urology › Product code KNS · Class 2
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation 876.4300
4510(k)s in 12 months (189 all time)
43recalls in 12 months (125 all time)
122recalls that name a 510(k)
Top companies in KNS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 17, 2017 | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory Creo Medical, Ltd., GB | KNS |
| Jun 17, 2016 | K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long Sumitomo Bakelite Co., Ltd., JP | KNS |
| Mar 17, 2016 | K160417 | Rezum System Nxthera, Inc. | KNS |
| Mar 2, 2016 | K160241 | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 Olympus Medical Systems Corp., JP | KNS |
| Oct 8, 2015 | K150142 | Single Use Balloon Dilator V (with Knife) Olympus Medical Systems Corp., JP | KNS |
| Aug 27, 2015 | K150786 | Rezum System Nxthera, Inc. | KNS |
| Mar 31, 2015 | K141991 | SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP Olympus Medical Systems Copr. | KNS |
| Apr 2, 2014 | K133933 | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation | KNS |
| Jul 26, 2013 | K130623 | BARRX CHANNEL RFA ENDOSCOPIC CATHETER Covidien, LLC | KNS |
| Apr 11, 2013 | K122505 | SINGLE USE PRELOADED SPHINCTEROTOME V Olympus Medical Systems Corp. | KNS |
| Dec 14, 2012 | K123319 | GYRUS ACMI BICOAG HEMOSTASIS PROBE Olympus Surgical Technologies America | KNS |
| Aug 17, 2012 | K122203 | TRUETOME Boston Scientific Corp | KNS |
| Apr 14, 2011 | K110887 | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation | KNS |
| Oct 20, 2010 | K092571 | GYRUS ACMI BIOCOAG PROBE Gyrus Acmi, Inc. | KNS |
| Sep 7, 2010 | K102273 | MERIT BIPOLAR COAGULATION PROBE Merit Medical Systems, Inc. | KNS |
| Aug 2, 2010 | K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U Hobbs Medical, Inc. | KNS |
| May 21, 2010 | K101139 | PROSTIVA RF THERAPY MODEL 8929 HAND PIECE Medtronic, Inc. | KNS |
| Oct 30, 2009 | K092309 | SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L Olympus Medical Systems Corporation | KNS |
| Jun 10, 2009 | K083292 | HABIB ENDOHPB Emcision , Ltd., GB | KNS |
| Jun 9, 2009 | K083275 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 Max Endoscopy, Inc. | KNS |
| Dec 19, 2008 | K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 Apollo Endosurgery, Inc. | KNS |
| Oct 27, 2008 | K082464 | PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 Medtronic, Inc. | KNS |
| May 20, 2008 | K080946 | CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX Conmed Endoscopic Technologies, Inc. | KNS |
| Nov 29, 2007 | K072383 | HABIB ENDOBLATE Emcision , Ltd., GB | KNS |
| Jun 27, 2006 | K061684 | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME Medi-Globe Corporation | KNS |
| Nov 17, 2005 | K052413 | TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 Medtronic Vascular | KNS |
| Aug 5, 2005 | K052051 | OMNI SPHINCTEROTOME Wilson-Cook Medical, Inc. | KNS |
| Apr 22, 2005 | K050578 | COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE Cook Ireland, Ltd., IE | KNS |
| Aug 9, 2004 | K033135 | STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM Stryker Endoscopy | KNS |
| May 7, 2004 | K040981 | USW NEEDLEKNIFE PAPILLOTOME Wilson-Cook Medical, Inc. | KNS |
| Dec 19, 2003 | K033203 | WILSON-COOK TRI-TOME SELECT PLUS Wilson-Cook Medical, Inc. | KNS |
| Jun 27, 2003 | K031026 | ETI BIPOLAR HEMOSTATIC PROBE Endo-Therapeutics, Inc. | KNS |
| Mar 24, 2003 | K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT The Olympus Optical Co. | KNS |
| Feb 27, 2003 | K030315 | MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM Ultroid, LLC | KNS |
| Jan 14, 2003 | K023706 | ULTROID HEMORRHOID MANAGEMENT SYSTEM Ultroid, LLC | KNS |
| Oct 17, 2002 | K022595 | WILSON-COOK CYSTOTOME Wilson-Cook Medical, Inc. | KNS |
| Sep 27, 2002 | K021266 | ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 Ethicon Endo-Surgery, Inc. | KNS |
| Dec 11, 2001 | K012587 | RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE Vidamed, Inc. | KNS |
| Oct 19, 2001 | K013153 | AUTOTOME RX MODEL # 4515, 4516 Boston Scientific Corp | KNS |
| Jul 6, 2001 | K011787 | PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE Vidamed, Inc. | KNS |
| Mar 27, 2001 | K010568 | ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM Arthrocare Corp. | KNS |
| Feb 13, 2001 | K002583 | TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM Vidamed, Inc. | KNS |
| Jan 23, 2001 | K002236 | HORIZONS PAPILLOTOME Horizons Intl. Corp. | KNS |
| Dec 19, 2000 | K003569 | PLASMAKINETIC ENDOUROLOGY SYSTEM Gyrus Medical , Ltd., GB | KNS |
| Oct 5, 2000 | K002802 | RAPID EXCHANGE TAPERTOME Boston Scientific Corp | KNS |
| Apr 18, 2000 | K000508 | THERMOFLEX SYSTEM Argomed, Inc. | KNS |
| Dec 27, 1999 | K994166 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE Gyrus Medical , Ltd., GB | KNS |
| Dec 22, 1999 | K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH Telemed Systems, Inc. | KNS |
| Aug 26, 1999 | K991847 | THERMOFLEX SYSTEM Argomed, Inc. | KNS |
| Jun 29, 1999 | K990628 | GYRUS ENDOUROLOGY SYSTEM Gyrus Medical , Ltd., GB | KNS |
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