Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- FADStent, Ureteral2Product Code
- EXXProbe, Rectal, Non-Powered1Product Code
- EYDStirrups1Product Code
- EYHTable, Cysto, Non-Electrical1Product Code
- EYSRibdam1Product Code
- EZOUrethrotome2Product Code
- EZPRod, Colostomy2Product Code
- FARUnit, Electrosurgical2Product Code
- FASElectrode, Electrosurgical, Active, Urological2Product Code
- K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )2Cleared 510(K)
- K250522Multi4 System2Cleared 510(K)
- K240504PLASMA EDGE System2Cleared 510(K)
- K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge2Cleared 510(K)
- K210651Resection Electrodes with HF cable2Cleared 510(K)
- K210394Electrosurgical accessory2Cleared 510(K)
- K171965Resection Electrodes with HF cable2Cleared 510(K)
- K163090Plasma Edge System2Cleared 510(K)
- K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode2Cleared 510(K)
- K152092Resection Electrodes2Cleared 510(K)
- K120567GYRUS AMCI PK BUTTON ELECTRODE2Cleared 510(K)
- K120418ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES2Cleared 510(K)
- K102781RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS2Cleared 510(K)
- K100275WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS2Cleared 510(K)
- K093181GYRUS ACMI PK BUTTON ELECTRODE2Cleared 510(K)
- K091511MODERN MEDICAL RESECTOSCOPE ELECTRODES2Cleared 510(K)
- K061541KSEA BIPOLAR ELECTROTOME2Cleared 510(K)
- K053322MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS2Cleared 510(K)
- K050910ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS2Cleared 510(K)
- K050454OMNITECH FULGURATING ELECTRODE2Cleared 510(K)
- K050488TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES2Cleared 510(K)
- K031029ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM2Cleared 510(K)
- K031001ACMI VISTA CTR BIPOLAR LOOP ELECTRODE2Cleared 510(K)
- K022543ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM2Cleared 510(K)
- K991314COAGULOOP2Cleared 510(K)
- K981256ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE2Cleared 510(K)
- K973820USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE2Cleared 510(K)
- K974637ELECTRODES/PROBES/DEVICES2Cleared 510(K)
- K974516ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE2Cleared 510(K)
- K974515ENDOLAP RESECTOSCOPE ROLLER ELECTRODE2Cleared 510(K)
- K971512AMS COAGULOOP RESECTION ELECTRODE2Cleared 510(K)
- K970526ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP2Cleared 510(K)
- K970717VAPOR-TECH SLED ELECTRODE2Cleared 510(K)
- K964365RESECTOSCOPE CUTTING LOOP ELECTRODE2Cleared 510(K)
- K965093OMNITECH RESECTOSCOPE ROLLER ELECTRODE2Cleared 510(K)
- K965118ENDOCARE MONOPOLAR ELECTRODE2Cleared 510(K)
- K962653MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT2Cleared 510(K)
- K962538BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)2Cleared 510(K)
- K961841BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)2Cleared 510(K)
- K953983EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE2Cleared 510(K)
- K961702KSEA VAPORIZATION ELECTRODES2Cleared 510(K)
- K961069ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM2Cleared 510(K)
- K954710VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.2Cleared 510(K)
- K955531ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM2Cleared 510(K)
- K953453SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES2Cleared 510(K)
- K951863ROLLER ELECTRODE2Cleared 510(K)
- K951897POWER RESECTOSCOPE CUTTING LOOP2Cleared 510(K)
- K945191ENDOSCOPIC ACCESSORY2Cleared 510(K)
- K943879RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP2Cleared 510(K)
- K944795KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES2Cleared 510(K)
- K931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS2Cleared 510(K)
- K933174GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE2Cleared 510(K)
- K933173GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE2Cleared 510(K)
- K933175GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE2Cleared 510(K)
- K915219URETHRAL ELECTRODE SHEATH2Cleared 510(K)
- K905731FLEXIBLE ENDOSCOPIC ELECTRODE2Cleared 510(K)
- K903156CONTROL-TIP CYSTOSCOPIC ELECTRODES2Cleared 510(K)
- K903162FLEXIBLE ENDOSCOPIC ELECTRODES2Cleared 510(K)
- FBJCord, Electric For Transurethral Surgical Instrument2Product Code
- FBSSound, Metal, Interconnected1Product Code
- FCHTray, Biopsy, Without Biopsy Instruments1Product Code
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral2Product Code
- FDBPlate, Patient2Product Code
- FDGRetractor, Fiberoptic1Product Code
- FDISnare, Flexible2Product Code
- FDJSnare, Rigid Self-Opening2Product Code
- FDLWristlet, Patient Return2Product Code
- FEHElectrode, Flexible Suction Coagulator2Product Code
- FEOLithotriptor, Ultrasonic2Product Code
- FFDEvacuator, Bladder, Manually Operated1Product Code
- FFESystem, Water Jet Catheter, Renal2Product Code
- FFISystem, Alarm, Electrosurgical2Product Code
- FFKLithotriptor, Electro-Hydraulic2Product Code
- FFLDislodger, Stone, Basket, Ureteral, Metal2Product Code
- FFNClamp, Non-Electrical1Product Code
- FFORetractor, Self-Retaining1Product Code
- FFQSpeculum, Rectal1Product Code
- FFRDevice, Locking, For Intestinal Clamp1Product Code
- FGKTripsor, Stone, Bladder2Product Code
- FGMProbe And Director, Gastro-Urology1Product Code
- FGNRetractor, Non-Self-Retaining1Product Code
- FGODislodger, Stone, Flexible2Product Code
- FGWClamp, Electrical2Product Code
- FGXSnare, Non-Electrical1Product Code
- FHBHook, Gastro-Urology1Product Code
- FHCAdaptor To The Cord, For Transurethral Surgical Instrument2Product Code
- FHFSystem, Evacuator, Fluid2Product Code
- FHHCrusher, Spur, Colostomy1Product Code
- FHIRing, Laparotomy1Product Code
- FHKSpreader, Bladder Neck1Product Code
- FHLScoop1Product Code
- FHNLigator, Hemorrhoidal2Product Code
- FHQHolder, Needle, Gastroenterologic1Product Code
- FHYJelly, Contact, For Transurethral Surgical Instrument2Product Code
- FHZDesiccator, Transurethral2Product Code
- FKKClamp, Line1Product Code
- KGEForceps, Biopsy, Electric2Product Code
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2Product Code
- KOASurgical Instruments, G-U, Manual (And Accessories)1Product Code
- KQSTable, Cystometric, Non-Electric And Accessories1Product Code
- KQTEvacuator, Gastro-Urology2Product Code
- LQCLithotriptor, Biliary Mechanical2Product Code
- MMZTable, Cystometric, Electric2Product Code
- MNDLigator, Esophageal2Product Code
- NLRUnit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed2Product Code
- NLTSnare, Flexible, Reprocessed2Product Code
- NLUForceps, Biopsy, Electric, Reprocessed2Product Code
- NLVElectrode, Flexible Suction Coagulator, Reprocessed2Product Code
- NLWElectrode, Electrosurgical, Active, Urological, Reprocessed2Product Code
- NQTDislodger, Stone, Flexible, Ureteral, Reprocessed2Product Code
- NQUDislodger, Stone, Basket, Ureteral, Metal, Reprocessed2Product Code
- NWIElectrosurgical Electrode Kit2Product Code
- OLHOrchidometer1Product Code
- ONJDissolvable Gel For Preventing Ureteral Stone Migration2Product Code
- OOWApplicator For Rectal Suppository1Product Code
- PKLHemostatic Metal Clip For The Gi Tract2Product Code
- PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation2Product Code
- PRUGastric Lavage Kit (Adult Or Pediatric Use)2Product Code
- QGBUreteral Stent Accessories1Product Code
- PVYVasovasostomy Set1Product Code
- QNEEndoscopic Pancreatic Debridement Device2Product Code
- QAGEndoscopic Electrosurgical Clip Cutting System2Product Code
- LNKLaser For Gastro-Urology Use2Product Code
- MUKElectrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue2Product Code
- NEJSystem, Cryosurgical, Liquid Nitrogen, For Gastroenterology2Product Code
- PZPFluid Jet Removal System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- 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
ENDOSCOPIC ACCESSORY
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K945191
- 510(k) Type
- Traditional
- Applicant
- UN-I-MED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/3/1995
- Days to Decision
- 191 days
- Submission Type
- Summary