FDA 510(k) Applications Submitted by Kunal Gunjal
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K170640 |
03/02/2017 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
K170641 |
03/02/2017 |
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes |
Intuitive Surgical, Inc. |
K170644 |
03/02/2017 |
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) |
Intuitive Surgical, Inc. |
K170645 |
03/02/2017 |
da Vinci Xi EndoWrist Instruments and Accessories |
Intuitive Surgical, Inc. |
K170879 |
03/24/2017 |
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories |
Intuitive Surgical, Inc. |
K180964 |
04/12/2018 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
K151450 |
05/29/2015 |
Endoscope Sterilization Tray |
INTUITIVE SURGICAL, INC. |
K183107 |
11/08/2018 |
Intuitive Surgical Vessel Sealer Extend |
Intuitive Surgical, Inc. |
K203632 |
12/11/2020 |
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
Intuitive Surgical, Inc. |
K214095 |
12/28/2021 |
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments |
Intuitive Surgical, Inc. |
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