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
- 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
- K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)2Cleared 510(K)
- K242888Electrohydraulic Lithotriptor (TCS-B3-II)2Cleared 510(K)
- K230488EL27-Compact; Sterile EHL-Probes2Cleared 510(K)
- K202813URO-TOUCH 9 French Probe2Cleared 510(K)
- K191124Swiss LithoClast Trilogy2Cleared 510(K)
- K162119UreTron PF Series Probe2Cleared 510(K)
- K160198UreTron MultiProbe Lithotripter System2Cleared 510(K)
- K132795CYBERWAND STERILE PROBE SET2Cleared 510(K)
- K130368AUTOLITH TOUCH; URO TOUCH2Cleared 510(K)
- K123038SWISS LITHOBREAKER2Cleared 510(K)
- K120303CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM2Cleared 510(K)
- K111058URETRON MODEL URT2Cleared 510(K)
- K102169CYBERWAND LITHOTRIPTER2Cleared 510(K)
- K092033VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR2Cleared 510(K)
- K072422CYBERWAND STERILE PADS, MODEL: CW-RBPBX2Cleared 510(K)
- K062475LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM2Cleared 510(K)
- K052135CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER2Cleared 510(K)
- K011911SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX2Cleared 510(K)
- K011848CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE2Cleared 510(K)
- K012445EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)2Cleared 510(K)
- K011065INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)2Cleared 510(K)
- K002084MICROVASIVE LITHOTRIPTOR FLEXPROBE II2Cleared 510(K)
- K992114KSEA CALCUSPLIT2Cleared 510(K)
- K992251SWISS LITHOCLAST MULTIPURPOSE PROBE2Cleared 510(K)
- K990341ELECTRO MECHANICAL LITHOTRIPTOR2Cleared 510(K)
- K980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)2Cleared 510(K)
- K981233KSEA CALCUSPLIT2Cleared 510(K)
- K974796LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER2Cleared 510(K)
- K973788MICROVASIVE LIPTHOTRIPSY PROBES2Cleared 510(K)
- K974164SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE2Cleared 510(K)
- K963285EMS SWISS LITHOCLAST LITHOTRIPTER2Cleared 510(K)
- K951531SWISS LITHOCLAST LITHOTRIPTER2Cleared 510(K)
- K944571PULSE GUARD 3FR ELECTRODE2Cleared 510(K)
- K931755RIWOLITH 2280 PROBES2Cleared 510(K)
- K931779EHL PULSE GENERATOR2Cleared 510(K)
- K920410EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB2Cleared 510(K)
- K925396PULSE GUARD ELECTRODE2Cleared 510(K)
- K923822AUTOLITH-IEHL2Cleared 510(K)
- K914517SD-200IEHL(TM)2Cleared 510(K)
- K913487RIWOLITH 22802Cleared 510(K)
- K9145153 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION2Cleared 510(K)
- K9145169 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION2Cleared 510(K)
- K9145141.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION2Cleared 510(K)
- K9139551.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION2Cleared 510(K)
- K905553LITHOTRIPTOR SYSTEM MODEL 270802Cleared 510(K)
- K9033371.9 FRENCH LITHOTRIPTER ELECTRODE2Cleared 510(K)
- K8947042.5 FRENCH LITHOTRIPTOR ELECTRODE2Cleared 510(K)
- K895178TECHNOMED PULSOLITH LASER SYSTEM2Cleared 510(K)
- K885255MDL-1 LASERTRIPTER(TM)2Cleared 510(K)
- K890436TECHNOMED PULSOLITH LASER SYSTEM2Cleared 510(K)
- K883189MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS2Cleared 510(K)
- K880503MDL-1 LASERTRIPTER2Cleared 510(K)
- K8649043F ELECTRODE2Cleared 510(K)
- K863642CANDELA MODEL MDL-1 LASER LITHOTRIPTOR2Cleared 510(K)
- K8528745F ELECTRODE(LITHOTRIPTOR)2Cleared 510(K)
- K834228LITHOTRIPTOR ELECTRODE 4.5F2Cleared 510(K)
- K832566COAXIAL ELECTRODE #300A2Cleared 510(K)
- K8300864.5 F LITHOTRIPTOR ELECTRODE2Cleared 510(K)
- K822585LITHOTRIPTOR ELECTRODE 4.5F2Cleared 510(K)
- K822644RIWOLITH 21352Cleared 510(K)
- K802322MODEL SD-1 DISINTEGRATOR2Cleared 510(K)
- 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
KSEA CALCUSPLIT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K981233
- 510(k) Type
- Traditional
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/15/1998
- Days to Decision
- 73 days
- Submission Type
- Summary