FDA Product Code
FDA Product Code NAY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 166 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads | Intuitive Surgical, Inc. | 2017-03-10 | Traditional | PDF ↗ |
| K162973 | EndoWrist Suction Irrigator | Intuitive Surgical, Inc. | 2017-02-06 | Traditional | PDF ↗ |
| K161178 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017-01-19 | Traditional | PDF ↗ |
| K162411 | da Vinci Xi 12 8 mm Reducer | Intuitive Surgical, Inc. | 2016-09-21 | Special | PDF ↗ |
| K153276 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2016-08-07 | Traditional | PDF ↗ |
| K161271 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2016-07-11 | Special | PDF ↗ |
| K152892 | da Vinci Xi Surgical System | Intuitive Surgical | 2016-04-29 | Traditional | PDF ↗ |
| K152578 | da Vinci Surgical System, Model IS4000 | Intuitive Surgical, Inc. | 2016-03-30 | Traditional | PDF ↗ |
| K152448 | da Vinci Single-Site Instrument and Accessories | Intuitive Surgical, Inc. | 2016-03-09 | Traditional | PDF ↗ |
| K152421 | IS4000 Stapler 30 Instrument and Stapler 30 Reloads | Intuitive Surgical, Inc. | 2016-03-04 | Traditional | PDF ↗ |
| K151794 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2016-01-15 | Traditional | PDF ↗ |
| K150284 | IS4000 da Vinci EndoWrist Instruments | Intuitive Surgical, Inc. | 2015-05-15 | Special | PDF ↗ |
| K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps | Intuitive Surgical, Inc. | 2015-04-29 | Special | PDF ↗ |
| K143132 | IS4000 8mm Harmonic ACE Curved Shears | Intuitive Surgical, Inc. | 2015-04-02 | Traditional | PDF ↗ |
| K142683 | 12 mm Endoscopes and Accessories | Intuitive Surgical, Inc. | 2014-12-10 | Traditional | PDF ↗ |
| K143217 | 12 mm & Stapler Bladeless Obturators | Intuitive Surgical, Inc. | 2014-12-03 | Special | PDF ↗ |
| K141075 | SINGLE-SITE WRISTED NEEDLE DRIVER | Intuitive Surgical | 2014-09-26 | Traditional | PDF ↗ |
| K123329 | DA VINVI SURGICAL SYSTEM | Intuitive Surgical, Inc. | 2014-09-17 | Traditional | PDF ↗ |
| K141077 | DA VINCI FIREFLY IMAGING SYSTEM | Intuitive Surgical, Inc. | 2014-08-12 | Traditional | PDF ↗ |
| K140553 | ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS | Intuitive Surgical, Inc. | 2014-07-25 | Traditional | PDF ↗ |
| K140189 | ENDOWRIST VESSEL SEALER | Intuitive Surgical, Inc. | 2014-06-05 | Traditional | PDF ↗ |
| K131962 | DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES | Intuitive Surgical, Inc. | 2014-04-17 | Traditional | PDF ↗ |
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES | Intuitive Surgical, Inc. | 2014-03-28 | Traditional | PDF ↗ |
| K130266 | ENDOWRIST ONE VESSEL SEALER | Intuitive Surgical, Inc. | 2013-08-29 | Traditional | PDF ↗ |
| K122532 | DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES | Intuitive Surgical, Inc. | 2013-07-30 | Traditional | PDF ↗ |
| K130726 | DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK | Intuitive Surgical, Inc. | 2013-06-07 | Special | PDF ↗ |
| K123840 | CONNECT FOR DA VINCI SURGICAL SYSTEM(S) | Intuitive Surgical, Inc. | 2013-02-14 | Special | PDF ↗ |
| K123463 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS | Intuitive Surgical, Inc. | 2012-12-03 | Special | PDF ↗ |
| K121921 | INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS | Intuitive Surgical, Inc. | 2012-10-25 | Traditional | PDF ↗ |
| K113706 | ENDOWRIST STAPLER SYSTEM | Intuitive Surgical, Inc. | 2012-10-17 | Traditional | PDF ↗ |
| K120215 | SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE | Intuitive Surgical, Inc. | 2012-04-30 | Special | PDF ↗ |
| K110639 | ENDOWRIST ONE VESSEL SEALER | Intuitive Surgical, Inc. | 2011-12-28 | Traditional | PDF ↗ |
| K112208 | INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES | Intuitive Surgical, Inc. | 2011-12-08 | Traditional | PDF ↗ |
| K112263 | MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY | Intuitive Surgical, Inc. | 2011-10-07 | Special | PDF ↗ |
| K112584 | 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT | Intuitive Surgical, Inc. | 2011-09-29 | Special | PDF ↗ |
| K110451 | ENDOWRIST ONE SUCTION/IRRIGATOR | Intuitive Surgical, Inc. | 2011-08-26 | Traditional | PDF ↗ |
| K101581 | INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 | Intuitive Surgical, Inc. | 2011-04-08 | Traditional | PDF ↗ |
| K101743 | 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 | Intuitive Surgical, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K093217 | 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) | Intuitive Surgical, Inc. | 2010-01-21 | Traditional | PDF ↗ |
| K090993 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 | Intuitive Surgical, Inc. | 2009-12-16 | Traditional | PDF ↗ |
| K082497 | INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT | Intuitive Surgical, Inc. | 2009-05-07 | Traditional | PDF ↗ |
| K081137 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 | Intuitive Surgical, Inc. | 2009-02-18 | Traditional | PDF ↗ |
| K081207 | INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE | Intuitive Surgical, Inc. | 2008-12-19 | Traditional | PDF ↗ |
| K080291 | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER | Intuitive Surgical, Inc. | 2008-03-19 | Traditional | PDF ↗ |
| K070947 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER | Intuitive Surgical, Inc. | 2008-02-14 | Traditional | PDF ↗ |
| K072627 | INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER | Intuitive Surgical, Inc. | 2008-02-07 | Traditional | PDF ↗ |
| K063220 | DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 | Intuitive Surgical, Inc. | 2006-12-01 | Traditional | PDF ↗ |
| K061260 | INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 | Intuitive Surgical, Inc. | 2006-05-18 | Special | PDF ↗ |
| K060391 | INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 | Intuitive Surgical, Inc. | 2006-04-10 | Special | PDF ↗ |
| K050802 | MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS | Intuitive Surgical, Inc. | 2005-06-29 | Traditional | PDF ↗ |
| K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 | Intuitive Surgical, Inc. | 2005-04-29 | Traditional | PDF ↗ |
| K043288 | MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS | Intuitive Surgical, Inc. | 2005-03-03 | Traditional | PDF ↗ |
| K050005 | INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 | Intuitive Surgical, Inc. | 2005-01-25 | Special | PDF ↗ |
| K043153 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 | Intuitive Surgical, Inc. | 2004-12-15 | Special | PDF ↗ |
| K042855 | INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT | Intuitive Surgical, Inc. | 2004-11-12 | Special | PDF ↗ |
| K040237 | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS | Intuitive Surgical, Inc. | 2004-07-07 | Traditional | PDF ↗ |
| K040948 | INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 | Intuitive Surgical, Inc. | 2004-05-05 | Special | PDF ↗ |
| K030578 | BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM | Computer Motion, Inc. | 2003-06-24 | Traditional | PDF ↗ |
| K022574 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 | Intuitive Surgical, Inc. | 2002-11-12 | Traditional | PDF ↗ |
| K021152 | ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES | Computer Motion, Inc. | 2002-09-24 | Traditional | PDF ↗ |
| K021036 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 | Intuitive Surgical, Inc. | 2002-06-26 | Traditional | PDF ↗ |
| K012833 | INTUITIVE SURGICAL BIPOLAR FORCEPS | Intuitive Surgical, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K011281 | INTUITIVE SURGICAL ULTRASONIC SHEARS | Intuitive Surgical, Inc. | 2001-07-24 | Traditional | PDF ↗ |
| K011002 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 | Intuitive Surgical, Inc. | 2001-05-30 | Traditional | PDF ↗ |
| K002489 | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM | Intuitive Surgical, Inc. | 2001-03-02 | Traditional | PDF ↗ |
| K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | Intuitive Surgical, Inc. | 2000-07-11 | Traditional | PDF ↗ |
Product code NAY · Class II · Gastroenterology, Urology. Data: openFDA.