Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- LYKAngioscope2Product Code
- PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices2Product Code
- K253122Sim&Size2Cleared 510(K)
- K250160ANKYRAS2Cleared 510(K)
- K242124Sim&Size2Cleared 510(K)
- K230006Ankyras2Cleared 510(K)
- K222664Sim&Size2Cleared 510(K)
- K213838AneuGuide2Cleared 510(K)
- K212373Sim&Size2Cleared 510(K)
- K202322Sim&Size2Cleared 510(K)
- K190049Sim&Size2Cleared 510(K)
- K171534SurgicalPreview2Cleared 510(K)
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- 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
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Sim&Size
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K253122
- 510(k) Type
- Traditional
- Applicant
- Sim&Cure
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/23/2025
- Days to Decision
- 89 days
- Submission Type
- Summary