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 |
|---|---|---|---|
| Apr 29, 2005 | K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc. | NAY |
| Mar 3, 2005 | K043288 | MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS Intuitive Surgical, Inc. | NAY |
| Jan 25, 2005 | K050005 | INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 Intuitive Surgical, Inc. | NAY |
| Dec 15, 2004 | K043153 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 Intuitive Surgical, Inc. | NAY |
| Nov 12, 2004 | K042855 | INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT Intuitive Surgical, Inc. | NAY |
| Jul 7, 2004 | K040237 | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS Intuitive Surgical, Inc. | NAY |
| May 5, 2004 | K040948 | INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 Intuitive Surgical, Inc. | NAY |
| Jun 24, 2003 | K030578 | BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM Computer Motion, Inc. | NAY |
| Nov 12, 2002 | K022574 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 Intuitive Surgical, Inc. | NAY |
| Sep 24, 2002 | K021152 | ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES Computer Motion, Inc. | NAY |
| Jun 26, 2002 | K021036 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 Intuitive Surgical, Inc. | NAY |
| Nov 16, 2001 | K012833 | INTUITIVE SURGICAL BIPOLAR FORCEPS Intuitive Surgical, Inc. | NAY |
| Jul 24, 2001 | K011281 | INTUITIVE SURGICAL ULTRASONIC SHEARS Intuitive Surgical, Inc. | NAY |
| May 30, 2001 | K011002 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 Intuitive Surgical, Inc. | NAY |
| Mar 2, 2001 | K002489 | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM Intuitive Surgical, Inc. | NAY |
| Jul 11, 2000 | K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Intuitive Surgical, Inc. | NAY |
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