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
- 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
- K901723MDL-2000 LASERTRIPTER2Cleared 510(K)
- K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.2Cleared 510(K)
- K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.2Cleared 510(K)
- K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE2Cleared 510(K)
- K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE2Cleared 510(K)
- K875039ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY2Cleared 510(K)
- K880171MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL2Cleared 510(K)
- K871934MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE2Cleared 510(K)
- K871932MODEL 5050 SURGILASER FOR UROLOGY USE2Cleared 510(K)
- K873892SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE2Cleared 510(K)
- K873330KTP/532 LASER2Cleared 510(K)
- K872870LASER OPTICAL FIBERS - DISPOSABLE2Cleared 510(K)
- K871865SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE2Cleared 510(K)
- K872630ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.2Cleared 510(K)
- K872350FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE2Cleared 510(K)
- K872031UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM2Cleared 510(K)
- K871513SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI2Cleared 510(K)
- K871516SL-100 ND:YAG LASER FOR UROLOGIC SURGERY2Cleared 510(K)
- K871515SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING2Cleared 510(K)
- K871514SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID2Cleared 510(K)
- K871348SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE2Cleared 510(K)
- K871032MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.2Cleared 510(K)
- K871029MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.2Cleared 510(K)
- K87103110-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH2Cleared 510(K)
- K871030MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.2Cleared 510(K)
- K864948ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE2Cleared 510(K)
- K863428SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG2Cleared 510(K)
- K863583CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER2Cleared 510(K)
- K862598LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM2Cleared 510(K)
- K861955CONTACT TIPS2Cleared 510(K)
- K861331ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE2Cleared 510(K)
- K861173OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO2Cleared 510(K)
- K861903#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL2Cleared 510(K)
- K861047MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL2Cleared 510(K)
- K861046MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA2Cleared 510(K)
- K860357HGM, INC. LASERCATH (STERILE)2Cleared 510(K)
- K860496MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY2Cleared 510(K)
- K855100S.L.T. CONTACT LASER SYSTEM2Cleared 510(K)
- K855119S.L.T. CONTACT LASER2Cleared 510(K)
- K854669S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER2Cleared 510(K)
- K860152MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY2Cleared 510(K)
- K860063ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM2Cleared 510(K)
- K855197FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM2Cleared 510(K)
- K854027LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM2Cleared 510(K)
- K843628HOTIP HEMOSTATIC PROBE2Cleared 510(K)
- K852798FIBERLASE 100 MEDICAL LASER SYSTEM2Cleared 510(K)
- K850728MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE2Cleared 510(K)
- K850509ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM2Cleared 510(K)
- K844460ND. YAG LASER RECTAL PATHOLOGY2Cleared 510(K)
- K844459ND:YAG LASER UROLOGICAL SURGERY2Cleared 510(K)
- K843374ND-YAG LASER FOR PALLIATION OF GI MALIGN2Cleared 510(K)
- K843240LASER FOR GENITOURINARY APPLIC. 40002Cleared 510(K)
- K843293ND-YAG LASER FOR UROLOGICAL SURGERY2Cleared 510(K)
- K843156BIOLAS YAG 100 CILAS, ERCELAS YAG 1002Cleared 510(K)
- K841869COOPER LASERSONICS, 8000 ND.YAGLASER2Cleared 510(K)
- K840142YAG LASER 8000 - LOWER GI APPLICAT2Cleared 510(K)
- K833499FIBERLAS 100 MEDICAL SYSTEM2Cleared 510(K)
- K833557MEDILAS LASER2Cleared 510(K)
- K833480MOLECTRON MEDICAL ND:YAG LASER, MODEL 80002Cleared 510(K)
- 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
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K871031
- 510(k) Type
- Traditional
- Applicant
- DIRECTED ENERGY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/15/1987
- Days to Decision
- 60 days