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
- K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control2Cleared 510(K)
- K231400Bladeless Trocar – Artemis Lap Cannula2Cleared 510(K)
- K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)2Cleared 510(K)
- K231358Universal Seal (5-12 mm)2Cleared 510(K)
- K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26172Cleared 510(K)
- K230886Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control2Cleared 510(K)
- K231042Disposable Laparoscopic Trocar2Cleared 510(K)
- K223718HandX™ Self-Righting Needle Holder2Cleared 510(K)
- K223562Xpan Universal Trocar System2Cleared 510(K)
- K230491HandX™ Monopolar Scissors2Cleared 510(K)
- Show All 1347 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
- 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
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K232157
- 510(k) Type
- Special
- Applicant
- Stryker Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/18/2023
- Days to Decision
- 29 days
- Submission Type
- Summary