FDA Browser
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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
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)
Show All 138 Submissions
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 16 August 2024 at 11:05 pm
SU
/
subpart-b—diagnostic-devices
/
NAY
/
K231224
View Source
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231224
510(k) Type
Special
Applicant
Intuitive Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/12/2023
Days to Decision
14 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
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
Show All 138 Submissions
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
/
K231224
View Source
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231224
510(k) Type
Special
Applicant
Intuitive Surgical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/12/2023
Days to Decision
14 days
Submission Type
Summary