FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
GCI
Laryngoscope, Endoscope
2
Product Code
GCJ
Laparoscope, General & Plastic Surgery
2
Product Code
MFJ
Device, Endoscopic Suturing
2
Product Code
EPY
Speculum, Ent
1
Product Code
NAY
System, Surgical, Computer Controlled Instrument
2
Product Code
K
24
1814
da Vinci SP Instruments (SP1098)
2
Cleared 510(K)
K
24
1638
8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
2
Cleared 510(K)
K
23
3866
Senhance Surgical System
2
Cleared 510(K)
K
24
0502
da Vinci SP Surgical System (SP1098)
2
Cleared 510(K)
K
24
1284
da Vinci Surgical System (IS5000)
2
Cleared 510(K)
K
23
2773
da Vinci SP Surgical System (SP1098)
2
Cleared 510(K)
K
24
0723
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
2
Cleared 510(K)
K
23
2610
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
2
Cleared 510(K)
K
23
1798
da Vinci SP Surgical System
2
Cleared 510(K)
K
23
1224
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
2
Cleared 510(K)
K
23
0033
Da Vinci SP Surgical System (SP1098)
2
Cleared 510(K)
K
22
3095
Senhance Surgical System
2
Cleared 510(K)
K
22
2839
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
2
Cleared 510(K)
K
22
3080
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
2
Cleared 510(K)
K
22
2827
da Vinci Firefly Imaging System
2
Cleared 510(K)
K
21
4095
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
2
Cleared 510(K)
K
22
0889
Senhance Surgical System
2
Cleared 510(K)
K
21
3710
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
2
Cleared 510(K)
K
22
0023
8mm Monopolar Curved Scissors
2
Cleared 510(K)
K
21
1997
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
2
Cleared 510(K)
K
21
2101
da Vinci SP Firefly Imaging System
2
Cleared 510(K)
K
21
2747
Da Vinci SP Surgical System
2
Cleared 510(K)
K
21
2054
Senhance Surgical System
2
Cleared 510(K)
K
21
1784
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
2
Cleared 510(K)
K
21
1325
Senhance Surgical System
2
Cleared 510(K)
K
21
1316
da Vinci SP Surgical System (SP1098)
2
Cleared 510(K)
K
21
1595
da Vinci SP Surgical System (SP1098)
2
Cleared 510(K)
K
21
0918
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
2
Cleared 510(K)
K
20
2166
Senhance Surgical System
2
Cleared 510(K)
K
20
3632
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
2
Cleared 510(K)
K
20
2968
Da Vinci SP Surgical System
2
Cleared 510(K)
K
20
0473
SoloAsisst II, Voice Control
2
Cleared 510(K)
K
20
2834
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
2
Cleared 510(K)
K
20
2571
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
2
Cleared 510(K)
K
19
2717
da Vinci SP Surgical System
2
Cleared 510(K)
K
19
2803
da Vinci Xi Surgical System, da Vinci X Surgical System
2
Cleared 510(K)
K
18
3086
da Vinci X and Xi Surgical System
2
Cleared 510(K)
K
20
0049
Senhance Surgical System
2
Cleared 510(K)
K
19
1529
da Vinci Xi Surgical System, da Vinci X Surgical System
2
Cleared 510(K)
K
19
2877
Senhance Surgical System
2
Cleared 510(K)
K
19
1280
E-100 Electrosurgical Generator, SynchroSeal
2
Cleared 510(K)
K
19
1736
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
2
Cleared 510(K)
K
19
0999
SureForm 45 Curved Tip, SureForm 45 Gray Reload
2
Cleared 510(K)
K
19
1482
Senhance Surgical System
2
Cleared 510(K)
K
18
2371
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
2
Cleared 510(K)
K
18
3224
SureForm 45, SureForm 45 Reloads
2
Cleared 510(K)
K
18
2421
Senhance Ultrasonic System
2
Cleared 510(K)
K
18
3107
Intuitive Surgical Vessel Sealer Extend
2
Cleared 510(K)
K
18
3098
Senhance Surgical System
2
Cleared 510(K)
K
18
2140
da Vinci Xi Surgical System, da Vinci X Surgical System
2
Cleared 510(K)
K
18
1517
Senhance Surgical System
2
Cleared 510(K)
K
17
1947
SOLOASSIST II
2
Cleared 510(K)
K
18
0351
EndoWrist Mercury Bipolar Grasper
2
Cleared 510(K)
K
17
3585
da Vinci Xi Surgical System, da Vinci X Surgical System
2
Cleared 510(K)
K
17
3721
SureForm 60 and SureForm 60 Reloads
2
Cleared 510(K)
K
17
3906
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
2
Cleared 510(K)
K
17
3415
EndoWrist 5mm Thoracic Grasper
2
Cleared 510(K)
K
18
0163
TransEnterix Senhance Surgical System
2
Cleared 510(K)
K
17
3337
Intuitive Surgical EndoWrist Vessel Sealer Extend
2
Cleared 510(K)
K
17
3842
da Vinci Xi Surgical System, da Vinci X Surgical System
2
Cleared 510(K)
K
18
0033
8mm Monopolar Curved Scissors
2
Cleared 510(K)
K
17
2643
da Vinci Xi Surgical System; da Vinci X Surgical System
2
Cleared 510(K)
K
17
1120
Senhance Surgical Robotic System
2
Cleared 510(K)
K
17
0879
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
2
Cleared 510(K)
K
17
0641
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
2
Cleared 510(K)
K
17
1632
da Vinci Xi Surgical System
2
Cleared 510(K)
K
17
0875
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
2
Cleared 510(K)
K
17
0644
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
2
Cleared 510(K)
K
17
0645
da Vinci Xi EndoWrist Instruments and Accessories
2
Cleared 510(K)
K
17
1699
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
2
Cleared 510(K)
K
17
1426
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
2
Cleared 510(K)
K
17
0713
da Vinci Xi Surgical System
2
Cleared 510(K)
K
17
1388
EndoWrist Stapler 45 System and Stapler 45 Reloads
2
Cleared 510(K)
K
17
1294
da Vinci X Surgical System
2
Cleared 510(K)
K
17
0865
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
2
Cleared 510(K)
K
17
0508
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
2
Cleared 510(K)
K
16
2973
EndoWrist Suction Irrigator
2
Cleared 510(K)
K
16
1178
da Vinci Xi Surgical System
2
Cleared 510(K)
K
16
2411
da Vinci Xi 12 – 8 mm Reducer
2
Cleared 510(K)
K
15
3276
da Vinci Xi Surgical System
2
Cleared 510(K)
K
16
1271
da Vinci Xi Surgical System
2
Cleared 510(K)
K
15
2892
da Vinci Xi Surgical System
2
Cleared 510(K)
K
15
2578
da Vinci Surgical System, Model IS4000
2
Cleared 510(K)
K
15
2448
da Vinci Single-Site Instrument and Accessories
2
Cleared 510(K)
K
15
2421
IS4000 Stapler 30 Instrument and Stapler 30 Reloads
2
Cleared 510(K)
K
15
1794
da Vinci Xi Surgical System
2
Cleared 510(K)
K
15
0284
IS4000 da Vinci EndoWrist Instruments
2
Cleared 510(K)
K
15
0837
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
2
Cleared 510(K)
K
14
3132
IS4000 8mm Harmonic ACE Curved Shears
2
Cleared 510(K)
K
14
2683
12 mm Endoscopes and Accessories
2
Cleared 510(K)
K
14
3217
12 mm & Stapler Bladeless Obturators
2
Cleared 510(K)
K
14
1075
SINGLE-SITE WRISTED NEEDLE DRIVER
2
Cleared 510(K)
K
12
3329
DA VINVI SURGICAL SYSTEM
2
Cleared 510(K)
K
14
1077
DA VINCI FIREFLY IMAGING SYSTEM
2
Cleared 510(K)
K
14
0553
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
2
Cleared 510(K)
K
14
0189
ENDOWRIST VESSEL SEALER
2
Cleared 510(K)
K
13
1962
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
2
Cleared 510(K)
K
13
1861
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
2
Cleared 510(K)
K
13
0266
ENDOWRIST ONE VESSEL SEALER
2
Cleared 510(K)
K
12
2532
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
2
Cleared 510(K)
K
13
0726
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
2
Cleared 510(K)
K
12
3840
CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
2
Cleared 510(K)
K
12
3463
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
2
Cleared 510(K)
K
12
1921
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
2
Cleared 510(K)
K
11
3706
ENDOWRIST STAPLER SYSTEM
2
Cleared 510(K)
K
12
0215
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
2
Cleared 510(K)
K
11
0639
ENDOWRIST ONE VESSEL SEALER
2
Cleared 510(K)
K
11
2208
INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
2
Cleared 510(K)
K
11
2263
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
2
Cleared 510(K)
K
11
2584
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
2
Cleared 510(K)
K
11
0451
ENDOWRIST ONE SUCTION/IRRIGATOR
2
Cleared 510(K)
K
10
1581
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
2
Cleared 510(K)
K
10
1743
5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
2
Cleared 510(K)
K
09
3217
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
2
Cleared 510(K)
K
09
0993
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
2
Cleared 510(K)
K
08
2497
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
2
Cleared 510(K)
K
08
1137
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
2
Cleared 510(K)
K
08
1207
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
2
Cleared 510(K)
K
08
0291
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
2
Cleared 510(K)
K
07
0947
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER
2
Cleared 510(K)
K
07
2627
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
2
Cleared 510(K)
K
06
3220
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
2
Cleared 510(K)
K
06
1260
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
2
Cleared 510(K)
K
06
0391
INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
2
Cleared 510(K)
K
05
0802
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
05
0369
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
2
Cleared 510(K)
K
04
3288
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
05
0005
INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
2
Cleared 510(K)
K
04
3153
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
2
Cleared 510(K)
K
04
2855
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
2
Cleared 510(K)
K
04
0237
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
04
0948
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
2
Cleared 510(K)
K
03
0578
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
2
Cleared 510(K)
K
02
2574
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200
2
Cleared 510(K)
K
02
1152
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
02
1036
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
2
Cleared 510(K)
K
01
2833
INTUITIVE SURGICAL BIPOLAR FORCEPS
2
Cleared 510(K)
K
01
1281
INTUITIVE SURGICAL ULTRASONIC SHEARS
2
Cleared 510(K)
K
01
1002
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
2
Cleared 510(K)
K
00
2489
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
2
Cleared 510(K)
K
99
0144
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
2
Cleared 510(K)
NEQ
Device, Telemedicine, Robotic
2
Product Code
PDT
Burn Resuscitation Decision Support Software
2
Product Code
FDP
Apparatus, Pneumoperitoneum, Automatic
2
Product Code
GCG
Peritoneoscope
2
Product Code
GCH
Mediastinoscope, Diagnostic
2
Product Code
OTJ
Laparoscopic Single Port Access Device
2
Product Code
OWN
Confocal Optical Imaging
2
Product Code
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
2
Product Code
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
2
Product Code
POY
Post Breast Biopsy Hemostatic Breast Compression Device
2
Product Code
FXE
Speculum, Non-Illuminated
1
Product Code
FXF
Speculum, Illuminated
1
Product Code
FXG
Specula Accessories
1
Product Code
JYK
Holder, Ear Speculum
1
Product Code
KAG
Holder, Speculum, Ent
1
Product Code
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
2
Product Code
QZB
Software Controlled Endoscope And Instrument Holder
2
Product Code
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
SU
/
subpart-b—diagnostic-devices
/
NAY
/
K072627
View Source
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K072627
510(k) Type
Traditional
Applicant
INTUITIVE SURGICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/7/2008
Days to Decision
143 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
GCI
Laryngoscope, Endoscope
GCJ
Laparoscope, General & Plastic Surgery
MFJ
Device, Endoscopic Suturing
EPY
Speculum, Ent
NAY
System, Surgical, Computer Controlled Instrument
K
24
1814
da Vinci SP Instruments (SP1098)
K
24
1638
8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
K
23
3866
Senhance Surgical System
K
24
0502
da Vinci SP Surgical System (SP1098)
K
24
1284
da Vinci Surgical System (IS5000)
K
23
2773
da Vinci SP Surgical System (SP1098)
K
24
0723
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
K
23
2610
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
K
23
1798
da Vinci SP Surgical System
K
23
1224
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K
23
0033
Da Vinci SP Surgical System (SP1098)
K
22
3095
Senhance Surgical System
K
22
2839
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
K
22
3080
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
K
22
2827
da Vinci Firefly Imaging System
K
21
4095
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
K
22
0889
Senhance Surgical System
K
21
3710
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
K
22
0023
8mm Monopolar Curved Scissors
K
21
1997
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
K
21
2101
da Vinci SP Firefly Imaging System
K
21
2747
Da Vinci SP Surgical System
K
21
2054
Senhance Surgical System
K
21
1784
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K
21
1325
Senhance Surgical System
K
21
1316
da Vinci SP Surgical System (SP1098)
K
21
1595
da Vinci SP Surgical System (SP1098)
K
21
0918
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
K
20
2166
Senhance Surgical System
K
20
3632
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
K
20
2968
Da Vinci SP Surgical System
K
20
0473
SoloAsisst II, Voice Control
K
20
2834
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K
20
2571
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
K
19
2717
da Vinci SP Surgical System
K
19
2803
da Vinci Xi Surgical System, da Vinci X Surgical System
K
18
3086
da Vinci X and Xi Surgical System
K
20
0049
Senhance Surgical System
K
19
1529
da Vinci Xi Surgical System, da Vinci X Surgical System
K
19
2877
Senhance Surgical System
K
19
1280
E-100 Electrosurgical Generator, SynchroSeal
K
19
1736
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
K
19
0999
SureForm 45 Curved Tip, SureForm 45 Gray Reload
K
19
1482
Senhance Surgical System
K
18
2371
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
K
18
3224
SureForm 45, SureForm 45 Reloads
K
18
2421
Senhance Ultrasonic System
K
18
3107
Intuitive Surgical Vessel Sealer Extend
K
18
3098
Senhance Surgical System
K
18
2140
da Vinci Xi Surgical System, da Vinci X Surgical System
K
18
1517
Senhance Surgical System
K
17
1947
SOLOASSIST II
K
18
0351
EndoWrist Mercury Bipolar Grasper
K
17
3585
da Vinci Xi Surgical System, da Vinci X Surgical System
K
17
3721
SureForm 60 and SureForm 60 Reloads
K
17
3906
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
K
17
3415
EndoWrist 5mm Thoracic Grasper
K
18
0163
TransEnterix Senhance Surgical System
K
17
3337
Intuitive Surgical EndoWrist Vessel Sealer Extend
K
17
3842
da Vinci Xi Surgical System, da Vinci X Surgical System
K
18
0033
8mm Monopolar Curved Scissors
K
17
2643
da Vinci Xi Surgical System; da Vinci X Surgical System
K
17
1120
Senhance Surgical Robotic System
K
17
0879
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
K
17
0641
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
K
17
1632
da Vinci Xi Surgical System
K
17
0875
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
K
17
0644
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
K
17
0645
da Vinci Xi EndoWrist Instruments and Accessories
K
17
1699
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
K
17
1426
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
K
17
0713
da Vinci Xi Surgical System
K
17
1388
EndoWrist Stapler 45 System and Stapler 45 Reloads
K
17
1294
da Vinci X Surgical System
K
17
0865
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
K
17
0508
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
K
16
2973
EndoWrist Suction Irrigator
K
16
1178
da Vinci Xi Surgical System
K
16
2411
da Vinci Xi 12 – 8 mm Reducer
K
15
3276
da Vinci Xi Surgical System
K
16
1271
da Vinci Xi Surgical System
K
15
2892
da Vinci Xi Surgical System
K
15
2578
da Vinci Surgical System, Model IS4000
K
15
2448
da Vinci Single-Site Instrument and Accessories
K
15
2421
IS4000 Stapler 30 Instrument and Stapler 30 Reloads
K
15
1794
da Vinci Xi Surgical System
K
15
0284
IS4000 da Vinci EndoWrist Instruments
K
15
0837
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
K
14
3132
IS4000 8mm Harmonic ACE Curved Shears
K
14
2683
12 mm Endoscopes and Accessories
K
14
3217
12 mm & Stapler Bladeless Obturators
K
14
1075
SINGLE-SITE WRISTED NEEDLE DRIVER
K
12
3329
DA VINVI SURGICAL SYSTEM
K
14
1077
DA VINCI FIREFLY IMAGING SYSTEM
K
14
0553
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
K
14
0189
ENDOWRIST VESSEL SEALER
K
13
1962
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
K
13
1861
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
K
13
0266
ENDOWRIST ONE VESSEL SEALER
K
12
2532
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
K
13
0726
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
K
12
3840
CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
K
12
3463
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
K
12
1921
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
K
11
3706
ENDOWRIST STAPLER SYSTEM
K
12
0215
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
K
11
0639
ENDOWRIST ONE VESSEL SEALER
K
11
2208
INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
K
11
2263
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
K
11
2584
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
K
11
0451
ENDOWRIST ONE SUCTION/IRRIGATOR
K
10
1581
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
K
10
1743
5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
K
09
3217
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
K
09
0993
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
K
08
2497
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
K
08
1137
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
K
08
1207
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
K
08
0291
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
K
07
0947
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER
K
07
2627
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
K
06
3220
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
K
06
1260
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
K
06
0391
INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
K
05
0802
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K
05
0369
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
K
04
3288
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K
05
0005
INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
K
04
3153
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
K
04
2855
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
K
04
0237
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K
04
0948
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170
K
03
0578
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
K
02
2574
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200
K
02
1152
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
K
02
1036
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
K
01
2833
INTUITIVE SURGICAL BIPOLAR FORCEPS
K
01
1281
INTUITIVE SURGICAL ULTRASONIC SHEARS
K
01
1002
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
K
00
2489
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
K
99
0144
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
NEQ
Device, Telemedicine, Robotic
PDT
Burn Resuscitation Decision Support Software
FDP
Apparatus, Pneumoperitoneum, Automatic
GCG
Peritoneoscope
GCH
Mediastinoscope, Diagnostic
OTJ
Laparoscopic Single Port Access Device
OWN
Confocal Optical Imaging
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
POY
Post Breast Biopsy Hemostatic Breast Compression Device
FXE
Speculum, Non-Illuminated
FXF
Speculum, Illuminated
FXG
Specula Accessories
JYK
Holder, Ear Speculum
KAG
Holder, Speculum, Ent
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
QZB
Software Controlled Endoscope And Instrument Holder
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-b—diagnostic-devices
/
NAY
/
K072627
View Source
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K072627
510(k) Type
Traditional
Applicant
INTUITIVE SURGICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/7/2008
Days to Decision
143 days
Submission Type
Summary