Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
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- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- GCILaryngoscope, Endoscope2Product Code
- GCJLaparoscope, General & Plastic Surgery2Product Code
- MFJDevice, Endoscopic Suturing2Product Code
- EPYSpeculum, Ent1Product Code
- NAYSystem, Surgical, Computer Controlled Instrument2Product Code
- K251426da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K251817da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K251227da Vinci Surgical System (IS5000)2Cleared 510(K)
- K251324da Vinci SP Surgical System (SP1098)2Cleared 510(K)
- K252350da Vinci SP Firefly Imaging System2Cleared 510(K)
- K250442da Vinci Surgical System, IS50002Cleared 510(K)
- K251213Da Vinci Surgical System (IS5000)2Cleared 510(K)
- K251202da Vinci Surgical System (IS5000)2Cleared 510(K)
- K250674Vessel Sealer Curved (480522)2Cleared 510(K)
- K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)2Cleared 510(K)
Show All 157 Submissions
- NEQDevice, Telemedicine, Robotic2Product Code
- PDTBurn Resuscitation Decision Support Software2Product Code
- FDPApparatus, Pneumoperitoneum, Automatic2Product Code
- GCGPeritoneoscope2Product Code
- GCHMediastinoscope, Diagnostic2Product Code
- OTJLaparoscopic Single Port Access Device2Product Code
- OWNConfocal Optical Imaging2Product Code
- QGYMobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera2Product Code
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)2Product Code
- POYPost Breast Biopsy Hemostatic Breast Compression Device2Product Code
- FXESpeculum, Non-Illuminated1Product Code
- FXFSpeculum, Illuminated1Product Code
- FXGSpecula Accessories1Product Code
- JYKHolder, Ear Speculum1Product Code
- KAGHolder, Speculum, Ent1Product Code
- QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured2Product Code
- QZBSoftware Controlled Endoscope And Instrument Holder2Product Code
- SFEEndoscopic Video Imaging System / Software Component For Real Time Video Augmentation2Product Code
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
da Vinci SP Firefly Imaging System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K252350
- 510(k) Type
- Special
- Applicant
- Intuitive Surgical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/28/2025
- Days to Decision
- 30 days
- Submission Type
- Summary