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
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- HERPelvimeter, External1Product Code
- FHGBell, Circumcision2Product Code
- FHJShield, Circumcision2Product Code
- HCYCurette, Uterine1Product Code
- HCZForceps, Surgical, Gynecological2Product Code
- HDAForceps, Obstetrical2Product Code
- HDBExtractor, Vacuum, Fetal2Product Code
- HDCTenaculum, Uterine2Product Code
- HDDTable, Obstetrical, Ac-Powered (And Accessories)2Product Code
- HDEHook, Fibroid, Gynecological1Product Code
- HDFSpeculum, Vaginal, Metal1Product Code
- HDGSpeculum, Vaginal, Metal, Fiberoptic1Product Code
- HDHNeedle, Cerclage, Gynecological1Product Code
- HDIHook, Destructive, Obstetrical2Product Code
- HDJScissors, Umbilical1Product Code
- HDKScissors, Episiotomy1Product Code
- HDLRetractor, Vaginal1Product Code
- HDMPacker, Uterine1Product Code
- HDNDilator, Cervical, Expandable3Product Code
- HDPElevator, Uterine2Product Code
- HDQDilator, Cervical, Fixed Size1Product Code
- HDYDilator, Cervical, Hygroscopic-Laminaria2Product Code
- HDZKnife, Cervical Cone2Product Code
- HFBForceps, Biopsy, Gynecological1Product Code
- HFGCoagulator, Laparoscopic, Unipolar (And Accessories)2Product Code
- HFHCoagulator, Hysteroscopic (And Accessories)2Product Code
- HFICoagulator, Culdoscopic (And Accessories)2Product Code
- HFWClamp, Umbilical2Product Code
- HFXClamp, Circumcision2Product Code
- HFZCraniotribe2Product Code
- HGACranioclast2Product Code
- HGCClamp, Uterine1Product Code
- HGDApplicator, Vaginal1Product Code
- HGEAmniotome1Product Code
- HGIElectrocautery, Gynecologic (And Accessories)2Product Code
- HHFRemover, Intrauterine Device, Contraceptive, Hook-Type1Product Code
- HHGDilator, Cervical, Vibratory3Product Code
- HHMSound, Uterine1Product Code
- HHNCleidoclast2Product Code
- HHOScrew, Fibroid, Gynecological2Product Code
- HHPTable, Obstetrical, Manual (And Accessories)2Product Code
- HHRLaser, Surgical, Gynecologic2Product Code
- K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES2Cleared 510(K)
- K871875MODEL 5050 SURGILASER FOR OB-GYN USE2Cleared 510(K)
- K875314GL-35 COLPOSCOPIC LASER SYSTEM2Cleared 510(K)
- K874615LASER CANNISTER FILTER2Cleared 510(K)
- K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE2Cleared 510(K)
- K880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE2Cleared 510(K)
- K880991LASER OPTICAL CATHETER SYSTEM2Cleared 510(K)
- K880173MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION2Cleared 510(K)
- K874837KTP/532 LASER FOR OB-GYN USE2Cleared 510(K)
- K875078HERACURE LS 5002Cleared 510(K)
- K872709MODEL 20-C, RL-20A/U, OB-10A/U2Cleared 510(K)
- K870841MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN2Cleared 510(K)
- K864946ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE2Cleared 510(K)
- K872352FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA2Cleared 510(K)
- K872254SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL2Cleared 510(K)
- K871579MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE2Cleared 510(K)
- K872253CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA2Cleared 510(K)
- K871220MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.2Cleared 510(K)
- K870046DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET2Cleared 510(K)
- K864378CO2 LASER MICROMANIPULATOR2Cleared 510(K)
- K863221OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN2Cleared 510(K)
- K863361MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA2Cleared 510(K)
- K862861SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE2Cleared 510(K)
- K863520CO2 LASER MICROMANIPULATOR2Cleared 510(K)
- K862444FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA2Cleared 510(K)
- K862228CABOT LASER LAPAROSCOPY ACCESSORY SET2Cleared 510(K)
- K862227MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN2Cleared 510(K)
- K862456ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION2Cleared 510(K)
- K861845MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE2Cleared 510(K)
- K855093MEDILAS 2 ND:YAG LASER SURGERY SYSTEM2Cleared 510(K)
- K853903ENDO-LASE CD40 CO2 FOR GYNECOLOGY2Cleared 510(K)
- K853876ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY2Cleared 510(K)
- K860329FYODOROV RADIAL KERATOTOMY MARKER SET2Cleared 510(K)
- K854470PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI2Cleared 510(K)
- K854361CO2 LASER LAPAROSCOPE SYSTEM2Cleared 510(K)
- K851425MODEL J25-25 WATT CO2 LASER2Cleared 510(K)
- K852694PORTALASE 200 CARBON SURGICAL LASER SYSTEM2Cleared 510(K)
- K844829ABDOMINAL PRESSURE CONTROL VALVE2Cleared 510(K)
- K844431YN CO2 LASER SYSTEM 30W2Cleared 510(K)
- K833528CARBON DIOXIDE LASER ML 8252Cleared 510(K)
- K843515MINUTEMAN CO2 MICROSURGICAL LASER GYN2Cleared 510(K)
- K820261MONITOR CO2 LASER SYSTEM2Cleared 510(K)
- K810562CARBON DIOXIDE (C02) MICROSURGICAL LASER2Cleared 510(K)
- K801197CO2 LASER2Cleared 510(K)
- K800227ML-800 CO22Cleared 510(K)
- K782054LASER, CO2 SURGICAL2Cleared 510(K)
- K772023OB/GYN LASER, MODEL 9202Cleared 510(K)
- K761347COLPOSCOPICALLY DIRECTED OB/GYN LASER2Cleared 510(K)
- HHTSpatula, Cervical, Cytological2Product Code
- HIBSpeculum, Vaginal, Nonmetal2Product Code
- HICSpeculum, Vaginal, Nonmetal, Fiberoptic2Product Code
- HIMElectrocautery, Endoscopic And Accessories2Product Code
- HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)2Product Code
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic2Product Code
- KNBInstrument, Destructive, Fetal, Obstetric2Product Code
- KNCTable, Obstetric (And Accessories)2Product Code
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)2Product Code
- KOHInstrument, Manual, General Obstetric-Gynecologic1Product Code
- LBXPelvimeter, Internal2Product Code
- LKFCannula, Manipulator/Injector, Uterine2Product Code
- LLWLaser, Neodymium:Yag For Gynecologic Use2Product Code
- MDGSystem, Intrafallopian Cannula2Product Code
- MLSLabor And Delivery Kit2Product Code
- MLTPelvic Exam Kit2Product Code
- MOVCatheters, Salpingography2Product Code
- MPUSource, Chemiluminescent Light2Product Code
- NBZClamp And Cutter, Umbilical2Product Code
- NMGForceps, Biopsy, Gynecological, Reprocessed2Product Code
- OHCObstetrical Vacuum Delivery Kit2Product Code
- PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use2Product Code
- OHGCircumcision Tray2Product Code
- PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To Labor2Product Code
- OHLPap Smear Kit2Product Code
- OJFHysterectomy Kit2Product Code
- PGKCannula, Injector, Uterine, Endometrial Biopsy2Product Code
- PKNDilator, Cervical, Synthetic, Osmotic2Product Code
- OKUEmergency Obstetrical Kit1Product Code
- OKVObstetrical Kit2Product Code
- OKYCytology Kit2Product Code
- OQYIntrauterine Tamponade Balloon2Product Code
- PMUContainment System, Laparoscopic Power Morcellation, With Instrument Port2Product Code
- PONCatheter, Balloon, Dilation Of Cervical Canal2Product Code
- PUATenaculum, Uterine, Exempt2Product Code
- PVRD&C Tray2Product Code
- PVXVaginal Examination Tray2Product Code
- PWBFetal Head Elevator2Product Code
- PWIInstrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse2Product Code
- PWKInstrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse2Product Code
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K861845
- 510(k) Type
- Traditional
- Applicant
- DIRECTED ENERGY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/11/1986
- Days to Decision
- 90 days