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
- 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
- K250705Sonata Transcervical Fibroid Ablation System 2.22Cleared 510(K)
- K240503Sonata Transcervical Fibroid Ablation System 2.22Cleared 510(K)
- K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)2Cleared 510(K)
- K222304Sonata Transcervical Fibroid Ablation System 2.22Cleared 510(K)
- K211535Sonata Transcervical Fibroid Ablation System 2.22Cleared 510(K)
- K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.12Cleared 510(K)
- K173703Sonata Sonography-Guided Transcervical Fibroid Ablation System2Cleared 510(K)
- K132135LINA GOLD LOOP HC2Cleared 510(K)
- K121343MODULAP LOOP2Cleared 510(K)
- K103726JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K092897LAP LOOP2Cleared 510(K)
- K070315LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-82Cleared 510(K)
- K022979LAPARETTE, MODEL LAP J L S H N2Cleared 510(K)
- K010752AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY2Cleared 510(K)
- K003405ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO2Cleared 510(K)
- K010425EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)2Cleared 510(K)
- K981463OMNITECH RESECTOSCOPE ROLLER ELECTRODE2Cleared 510(K)
- K981464OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE2Cleared 510(K)
- K970961VAPORIZATION ELECTRODES2Cleared 510(K)
- K972856ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS2Cleared 510(K)
- K971838MICRO ELECTRODES2Cleared 510(K)
- K971146LAPARETTE2Cleared 510(K)
- K964594VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)2Cleared 510(K)
- K971621RESISTICK SOLID LAPAROSCOPIC ELECTRODES2Cleared 510(K)
- K964441FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU2Cleared 510(K)
- K953242SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES2Cleared 510(K)
- K952070NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS2Cleared 510(K)
- K950499NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS2Cleared 510(K)
- K944862KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES2Cleared 510(K)
- K944793KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES2Cleared 510(K)
- K941207MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES2Cleared 510(K)
- K944297KARL STORZ INSULATED SCISSORS2Cleared 510(K)
- K944300KARL STORZ INSULATED BIOPSY FORCEPS2Cleared 510(K)
- K933300GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.2Cleared 510(K)
- K921727CORE MONITORING SYSTEM-SP1475/6275/5607/5708/45752Cleared 510(K)
- K932456JARIT SURGICAL INSTRUMENTS2Cleared 510(K)
- K921686ENDOMED LAPAROSCOPY INSTRUMENTS2Cleared 510(K)
- K935947HI-TOPS ELECTRODES 14-80002Cleared 510(K)
- K924200REFLEX(R) ESC2Cleared 510(K)
- K902658GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES2Cleared 510(K)
- K871960ELECTRO-GYNE ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K780955SCISSORS, HOOK, ELECTROSURGICAL2Cleared 510(K)
- K780954SCISSORS, HOOK, ELECTROSURGICAL2Cleared 510(K)
- K772220PROBE, COAGULATION ACCESSORY2Cleared 510(K)
- 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
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K964441
- 510(k) Type
- Traditional
- Applicant
- Gynecare Innovation Center
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/28/1997
- Days to Decision
- 142 days
- Submission Type
- Summary