Panels › Gastroenterology, Urology › Product code NAY · Class 2
System, Surgical, Computer Controlled Instrument
Regulation 876.1500
9510(k)s in 12 months (166 all time)
16recalls in 12 months (248 all time)
244recalls that name a 510(k)
Top companies in NAY
| Company | 510(k)s | Recalls |
|---|---|---|
| Intuitive Surgical | 147 | 246 |
| Transenterix, Inc. | 9 | 0 |
| Asensus Surgical | 6 | 1 |
| Aktormed GmbH | 2 | 0 |
| Computer Motion, Inc. | 2 | 0 |
| Olympus Corporation of the Americas | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2017 | K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Rel Intuitive Surgical, Inc. | NAY |
| Feb 6, 2017 | K162973 | EndoWrist Suction Irrigator Intuitive Surgical, Inc. | NAY |
| Jan 19, 2017 | K161178 | da Vinci Xi Surgical System Intuitive Surgical, Inc. | NAY |
| Sep 21, 2016 | K162411 | da Vinci Xi 12 8 mm Reducer Intuitive Surgical, Inc. | NAY |
| Aug 7, 2016 | K153276 | da Vinci Xi Surgical System Intuitive Surgical, Inc. | NAY |
| Jul 11, 2016 | K161271 | da Vinci Xi Surgical System Intuitive Surgical, Inc. | NAY |
| Apr 29, 2016 | K152892 | da Vinci Xi Surgical System Intuitive Surgical | NAY |
| Mar 30, 2016 | K152578 | da Vinci Surgical System, Model IS4000 Intuitive Surgical, Inc. | NAY |
| Mar 9, 2016 | K152448 | da Vinci Single-Site Instrument and Accessories Intuitive Surgical, Inc. | NAY |
| Mar 4, 2016 | K152421 | IS4000 Stapler 30 Instrument and Stapler 30 Reloads Intuitive Surgical, Inc. | NAY |
| Jan 15, 2016 | K151794 | da Vinci Xi Surgical System Intuitive Surgical, Inc. | NAY |
| May 15, 2015 | K150284 | IS4000 da Vinci EndoWrist Instruments Intuitive Surgical, Inc. | NAY |
| Apr 29, 2015 | K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps Intuitive Surgical, Inc. | NAY |
| Apr 2, 2015 | K143132 | IS4000 8mm Harmonic ACE Curved Shears Intuitive Surgical, Inc. | NAY |
| Dec 10, 2014 | K142683 | 12 mm Endoscopes and Accessories Intuitive Surgical, Inc. | NAY |
| Dec 3, 2014 | K143217 | 12 mm & Stapler Bladeless Obturators Intuitive Surgical, Inc. | NAY |
| Sep 26, 2014 | K141075 | SINGLE-SITE WRISTED NEEDLE DRIVER Intuitive Surgical | NAY |
| Sep 17, 2014 | K123329 | DA VINVI SURGICAL SYSTEM Intuitive Surgical, Inc. | NAY |
| Aug 12, 2014 | K141077 | DA VINCI FIREFLY IMAGING SYSTEM Intuitive Surgical, Inc. | NAY |
| Jul 25, 2014 | K140553 | ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS Intuitive Surgical, Inc. | NAY |
| Jun 5, 2014 | K140189 | ENDOWRIST VESSEL SEALER Intuitive Surgical, Inc. | NAY |
| Apr 17, 2014 | K131962 | DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES Intuitive Surgical, Inc. | NAY |
| Mar 28, 2014 | K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc. | NAY |
| Aug 29, 2013 | K130266 | ENDOWRIST ONE VESSEL SEALER Intuitive Surgical, Inc. | NAY |
| Jul 30, 2013 | K122532 | DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc. | NAY |
| Jun 7, 2013 | K130726 | DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK Intuitive Surgical, Inc. | NAY |
| Feb 14, 2013 | K123840 | CONNECT FOR DA VINCI SURGICAL SYSTEM(S) Intuitive Surgical, Inc. | NAY |
| Dec 3, 2012 | K123463 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS Intuitive Surgical, Inc. | NAY |
| Oct 25, 2012 | K121921 | INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS Intuitive Surgical, Inc. | NAY |
| Oct 17, 2012 | K113706 | ENDOWRIST STAPLER SYSTEM Intuitive Surgical, Inc. | NAY |
| Apr 30, 2012 | K120215 | SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE Intuitive Surgical, Inc. | NAY |
| Dec 28, 2011 | K110639 | ENDOWRIST ONE VESSEL SEALER Intuitive Surgical, Inc. | NAY |
| Dec 8, 2011 | K112208 | INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc. | NAY |
| Oct 7, 2011 | K112263 | MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY Intuitive Surgical, Inc. | NAY |
| Sep 29, 2011 | K112584 | 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT Intuitive Surgical, Inc. | NAY |
| Aug 26, 2011 | K110451 | ENDOWRIST ONE SUCTION/IRRIGATOR Intuitive Surgical, Inc. | NAY |
| Apr 8, 2011 | K101581 | INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 Intuitive Surgical, Inc. | NAY |
| Feb 4, 2011 | K101743 | 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 Intuitive Surgical, Inc. | NAY |
| Jan 21, 2010 | K093217 | 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) Intuitive Surgical, Inc. | NAY |
| Dec 16, 2009 | K090993 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 Intuitive Surgical, Inc. | NAY |
| May 7, 2009 | K082497 | INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT Intuitive Surgical, Inc. | NAY |
| Feb 18, 2009 | K081137 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 Intuitive Surgical, Inc. | NAY |
| Dec 19, 2008 | K081207 | INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE Intuitive Surgical, Inc. | NAY |
| Mar 19, 2008 | K080291 | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER Intuitive Surgical, Inc. | NAY |
| Feb 14, 2008 | K070947 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER Intuitive Surgical, Inc. | NAY |
| Feb 7, 2008 | K072627 | INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER Intuitive Surgical, Inc. | NAY |
| Dec 1, 2006 | K063220 | DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 Intuitive Surgical, Inc. | NAY |
| May 18, 2006 | K061260 | INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 Intuitive Surgical, Inc. | NAY |
| Apr 10, 2006 | K060391 | INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 Intuitive Surgical, Inc. | NAY |
| Jun 29, 2005 | K050802 | MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS Intuitive Surgical, Inc. | NAY |
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