Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- HRXArthroscope2Product Code
- K252458Kyphoplasty Balloon Dilatation Catheters2Cleared 510(K)
- K252594UltraGuideCTR® image guided soft tissue release system2Cleared 510(K)
- K243774ELID (Endoscopic Less Invasive Decompression) System2Cleared 510(K)
- K241990SpineSite Endoscope System2Cleared 510(K)
- K243602Arthrex Spine Endoscope2Cleared 510(K)
- K242417VECTR – Video Endoscopic Carpal Tunnel Release System2Cleared 510(K)
- K243020MIDASVu2Cleared 510(K)
- K233800Vertos mild Device Kit (MDK-0002)2Cleared 510(K)
- K240535Digital ClarusScope System; Digital NeuroPEN System2Cleared 510(K)
- K233675FMS VUE™ Fluid Management and Tissue Debridement System2Cleared 510(K)
Show All 674 Submissions
- LZEIsometer1Product Code
- NBHAccessories, Arthroscopic1Product Code
- NGRTester, Stiffness, Cartilage, Arthroscopic2Product Code
- PPRSurgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures2Product Code
- QGQBone Indentation Device2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SpineSite Endoscope System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K241990
- 510(k) Type
- Traditional
- Applicant
- Hydrocision, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/30/2025
- Days to Decision
- 387 days
- Submission Type
- Summary