Anesthesiology
Review Panel
- CardiovascularReview Panel
- 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
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- GCILaryngoscope, Endoscope2Product Code
- GCJLaparoscope, General & Plastic Surgery2Product Code
- K254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control2Cleared 510(K)
- K250927KARL STORZ Cholangiography Set2Cleared 510(K)
- K242606Nuvis® Wireless HD Camera System (Nuvis-2K)2Cleared 510(K)
- K252442Kii Structural Balloon Access System2Cleared 510(K)
- K2526973D Laparoscope2Cleared 510(K)
- K252640VereSee Optical Veres Needle and Endoscopic Camera2Cleared 510(K)
- K251994Arthrex Synergy Vision Imaging System2Cleared 510(K)
- K243968Revolve Surgical System2Cleared 510(K)
- K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)2Cleared 510(K)
- K251743SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System2Cleared 510(K)
Show All 1405 Submissions
- MFJDevice, Endoscopic Suturing2Product Code
- EPYSpeculum, Ent1Product Code
- NAYSystem, Surgical, Computer Controlled Instrument2Product Code
- 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
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K250551
- 510(k) Type
- Traditional
- Applicant
- Shenzhen Sophway Technology Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/2/2025
- Days to Decision
- 219 days
- Submission Type
- Summary