Anesthesiology
Review Panel
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- 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
- KOHInstrument, Manual, General Obstetric-Gynecologic1Product Code
- LBXPelvimeter, Internal2Product Code
- LKFCannula, Manipulator/Injector, Uterine2Product Code
- K242002FemVue MINI Saline-Air Device2Cleared 510(K)
- K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)2Cleared 510(K)
- K241693FemChec Controlled Saline-Air Device (FCD-250)2Cleared 510(K)
- K222798Rejoni Intrauterine Catheter2Cleared 510(K)
- K223064ALLY II Uterine Positioning System™ (UPS)2Cleared 510(K)
- K220202Uterine ElevatOR PRO with OccludOR Balloon2Cleared 510(K)
- K212505DUMI ManipulatOR2Cleared 510(K)
- K181770Intrauterine Access Balloon Catheter, Selective Salpingography Catheter2Cleared 510(K)
- K180300Margolin HSG Cannula, Goldstein Sonohysterography Catheter2Cleared 510(K)
- K180291Cook Silicone Balloon HSG Catheter2Cleared 510(K)
- K172846Uterine Manipulator2Cleared 510(K)
- K171604Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip2Cleared 510(K)
- K163214Unicare System, Unicare Manipulator2Cleared 510(K)
- K160217uVue HSG/SHG Catheter2Cleared 510(K)
- K153092Ally Uterine Positioning System2Cleared 510(K)
- K150519ManipulatOR PRO, ManipulatOR2Cleared 510(K)
- K142545SonoFlow Sonohysterography and Sonohysterosalpingography Device2Cleared 510(K)
- K143415Air Bubble Based Infuser (ABBI)2Cleared 510(K)
- K142716VCARE2Cleared 510(K)
- K142164MANIPULATOR; MANIPULATOR PRO2Cleared 510(K)
- K141523ALLY UPS2Cleared 510(K)
- K131781CLEARVIEW TOTAL2Cleared 510(K)
- K130758KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER2Cleared 510(K)
- K122820VIKY UP2Cleared 510(K)
- K123258THE ADVANCE CATHETER FOR HSG AND SIS2Cleared 510(K)
- K102898BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE2Cleared 510(K)
- K110993FEMCHEC PRESSURE MANAGEMET DEVICE2Cleared 510(K)
- K110288FEMVUE SALINE-AIR DEVICE2Cleared 510(K)
- K092983PANPAC HSG CATHETER SET2Cleared 510(K)
- K092969H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F2Cleared 510(K)
- K100662FEMVUE CORNUAL BALLOON CATHETER2Cleared 510(K)
- K092984PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.02Cleared 510(K)
- K093556VCARE DX2Cleared 510(K)
- K092980PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.52Cleared 510(K)
- K083594EZ HSG CATHETER.FOAMSEAL CATHETER2Cleared 510(K)
- K083690FEMVUE(TM) CATHETER SYSTEM2Cleared 510(K)
- K071405PROBE HOLDER SYSTEM2Cleared 510(K)
- K071907VCARE RETRACTOR/ELEVATOR2Cleared 510(K)
- K063611SALINE/ CONTRAST MEDIA INFUSION CATHETER2Cleared 510(K)
- K061679WALLACE ARTIFICIAL INSEMINATION CATHETER2Cleared 510(K)
- K041062INTRAUTERINE VENOGRAM NEEDLE SET2Cleared 510(K)
- K040238SOFTSEAL HSG CATHETER2Cleared 510(K)
- K041094HSG CATHETER SET2Cleared 510(K)
- K032835H/S CATHETER SET2Cleared 510(K)
- K023051INTRAUTERINE DELIVERY SYSTEM - INJECTOR2Cleared 510(K)
- K022503UTERINE INJECTOR2Cleared 510(K)
- K021272SIB CATHETER, MODEL 61-70052Cleared 510(K)
- K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY2Cleared 510(K)
- K020292UTERINE INJECTOR2Cleared 510(K)
- K020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-50072Cleared 510(K)
- K013972H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-40052Cleared 510(K)
- K013491HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-9482Cleared 510(K)
- K013437SF SH CATHETER, MODEL R65-9452Cleared 510(K)
- K010296UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-4502Cleared 510(K)
- K010056UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-4502Cleared 510(K)
- K000433PBN HYSTERO-SALPINGOGRAPHY CATHETER SET2Cleared 510(K)
- K001115ULTRA CATHETER SET2Cleared 510(K)
- K974357UTERINE MANIPULATOR/INJECTOR2Cleared 510(K)
- K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER2Cleared 510(K)
- K961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)2Cleared 510(K)
- K955446CONMED VCARE RETRACTOR/ELEVATOR2Cleared 510(K)
- K955508ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET2Cleared 510(K)
- K946220CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR2Cleared 510(K)
- K953034H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)2Cleared 510(K)
- K943494HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY2Cleared 510(K)
- K931167OVAMED FALLOPIAN OSTIAL ACCESS CATHETER2Cleared 510(K)
- K943448LUMIN2Cleared 510(K)
- K931122OVAMED HSG CATHETER2Cleared 510(K)
- K932394BERNSTEIN(TM) UTERINE MANIPULATOR2Cleared 510(K)
- K941458UTERINE MANIPULATOR/INJECTOR WITH SPRING2Cleared 510(K)
- K941457UTERINE INJECTOR WITH SPRING2Cleared 510(K)
- K935023GODAT UTERINE MANIPULATOR INJECTOR2Cleared 510(K)
- K933981CERVICAL CATHETER2Cleared 510(K)
- K933723CONCEPTUS UTERINE CATHETER2Cleared 510(K)
- K940681CLEARVIEW UTERINE MANIPULATOR2Cleared 510(K)
- K930867AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR2Cleared 510(K)
- K932115ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI2Cleared 510(K)
- K931814DMI UTERINE MOBILIZER/ELEVATOR/CANNULA2Cleared 510(K)
- K935434OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT2Cleared 510(K)
- K932432KRONNER REINFORCING STYLETTE2Cleared 510(K)
- K930038CANNULA: KAHN, JARCO, CORSON AND RATCHET2Cleared 510(K)
- K911887MAJOLI UTERINE MANIPULATOR/INJECTOR2Cleared 510(K)
- K904079BARD UTERINE MANIPULATOR2Cleared 510(K)
- K902975TWIN BALLOON INJECTOR2Cleared 510(K)
- K772230CANNULA, PERFUSION, FALLOPIAN TUBE2Cleared 510(K)
- 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
ManipulatOR PRO, ManipulatOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K150519
- 510(k) Type
- Traditional
- Applicant
- GYNETECH PTY. LTD.
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/19/2015
- Days to Decision
- 170 days
- Submission Type
- Summary