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
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MRHPump, Infusion, Ophthalmic2Product Code
- K243503VIA360™ Surgical System2Cleared 510(K)
- K232214OMNI Surgical System2Cleared 510(K)
- K213173TrabEx Pro2Cleared 510(K)
- K212797iPrime Viscodelivery System2Cleared 510(K)
- K211680Streamline Surgical System2Cleared 510(K)
- K202678OMNI Surgical System2Cleared 510(K)
- K201953OMNI PLUS Surgical System2Cleared 510(K)
- K173332OMNI Surgical System2Cleared 510(K)
- K171905VISCO 360 Viscosurgical System2Cleared 510(K)
- K143205Viscoelastic Injector2Cleared 510(K)
- K132494VISCOELASTIC INJECTOR2Cleared 510(K)
- K050716ISCIENCE SURGICAL VISCOINJECTOR2Cleared 510(K)
- K000420SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 100032Cleared 510(K)
- K993039VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)2Cleared 510(K)
- K981907V.F.I.-VISCOUS FLUID INFUSION TUBING SET2Cleared 510(K)
- K974253CPD COMMANDER2Cleared 510(K)
- K972664STORZ MILLENNIUM VISCOUS FLUID SYSTEM2Cleared 510(K)
- K971067DIGI-INJECTOR2Cleared 510(K)
- K963434VISCOUS FLUID SYSTEM2Cleared 510(K)
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
VISCOUS FLUID SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K963434
- 510(k) Type
- Traditional
- Applicant
- ESCALON TREK MEDICAL
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/25/1996
- Days to Decision
- 87 days
- Submission Type
- Statement