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
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)2Product Code
- HETLaparoscope, Gynecologic (And Accessories)2Product Code
- HEWCuldoscope (And Accessories)2Product Code
- HEXColposcope (And Colpomicroscope)2Product Code
- HEZEndoscope, Transcervical (Amnioscope)(And Accessories)2Product Code
- HFAAmnioscope, Transabdominal (Fetoscope) (And Accessories)FProduct Code
- HFCAspirator, Endocervical2Product Code
- HFDWasher, Endometrial2Product Code
- HFEBrush, Endometrial2Product Code
- HFFAspirator, Endometrial2Product Code
- HGKEndoscope, Fetal Blood Sampling (And Accessories)2Product Code
- HGWSampler, Blood, Fetal2Product Code
- HHKCurette, Suction, Endometrial (And Accessories)2Product Code
- HIFInsufflator, Laparoscopic2Product Code
- HIGInsufflator, Hysteroscopic2Product Code
- HIHHysteroscope (And Accessories)2Product Code
- K231260HTx Disposable Hysteroscope System2Cleared 510(K)
- K233635SPY Cystoscope/Hysteroscope2Cleared 510(K)
- K232003Endoscopic Video Image Processor, Single-Use Video Hysteroscope2Cleared 510(K)
- K233500Benesta Tissue Removal Device2Cleared 510(K)
- K223885HOPKINS Telescopes2Cleared 510(K)
- K223813Aveta System 2.02Cleared 510(K)
- K223520UNIDRIVE SIII System2Cleared 510(K)
- K221557Visera Hysterovideoscope Olympus HYF Type V2Cleared 510(K)
- K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)2Cleared 510(K)
- K213207Sheath, Stopcock Accessory2Cleared 510(K)
- K202445Hystero-V Hysteroscope2Cleared 510(K)
- K210270Medical Endoscope Image Processing System2Cleared 510(K)
- K211227HTx Disposable Hysteroscope System2Cleared 510(K)
- K192811BenestaTM Tissue Removal Device2Cleared 510(K)
- K201970Schoelly Cystoscopes/Hysteroscopes and Accessories2Cleared 510(K)
- K201756Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent2Cleared 510(K)
- K192822Benesta Hysteroscope2Cleared 510(K)
- K200038Endosee System2Cleared 510(K)
- K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module2Cleared 510(K)
- K191538Resectr Tissue Resection Device2Cleared 510(K)
- K192100Aveta Disposable Hysteroscope2Cleared 510(K)
- K190797Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)2Cleared 510(K)
- K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)2Cleared 510(K)
- K191958Aveta System2Cleared 510(K)
- K191281Omni Hysteroscope, Omni Lok cervical seal2Cleared 510(K)
- K191335Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags2Cleared 510(K)
- K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid2Cleared 510(K)
- K182975MAKO 72Cleared 510(K)
- K190372Aveta System2Cleared 510(K)
- K190639Endosee System2Cleared 510(K)
- K181545Hysteroscope System2Cleared 510(K)
- K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags2Cleared 510(K)
- K183020Endosee System2Cleared 510(K)
- K182675Polygon Resection Device2Cleared 510(K)
- K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths2Cleared 510(K)
- K180496TruClear Elite Hysteroscope2Cleared 510(K)
- K181974MyoSure XL Tissue Removal Device for Fluent2Cleared 510(K)
- K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole2Cleared 510(K)
- K173070HSW Resection Instruments2Cleared 510(K)
- K173901MyoSure MANUAL Tissue Removal Device2Cleared 510(K)
- K180096GDT-1000 System2Cleared 510(K)
- K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module2Cleared 510(K)
- K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices2Cleared 510(K)
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula2Cleared 510(K)
- K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device2Cleared 510(K)
- K160751Symphion Endoscope and Symphion Cervical Sheath2Cleared 510(K)
- K160510MAKO 72Cleared 510(K)
- K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices2Cleared 510(K)
- K151275MAKO Device2Cleared 510(K)
- K152143TRUCLEAR Operative Hysteroscope 5C and Sheath 5C2Cleared 510(K)
- K150158Schoelly Cystoscopes/Hysteroscopes and Accessories2Cleared 510(K)
- K141515AED HYSTEROSCOPE AND ACCESSORIES2Cleared 510(K)
- K142029MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM2Cleared 510(K)
- K132384U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA2Cleared 510(K)
- K132015TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS2Cleared 510(K)
- K131736MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)2Cleared 510(K)
- K131581MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)2Cleared 510(K)
- K123330IOGYN ENDOSCOPE2Cleared 510(K)
- K123151ENDOSEE MODEL 8000 U-SCOPE2Cleared 510(K)
- K122563MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL2Cleared 510(K)
- K122498MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)2Cleared 510(K)
- K121868MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)2Cleared 510(K)
- K120593MYOSURE CONTROL UNIT2Cleared 510(K)
- K112134TRUCLEAR OPERATIVE HYSTEROSCOPE2Cleared 510(K)
- K110038TRUCLEAR MORCELLATOR SYSTEM2Cleared 510(K)
- K103389TRUCLEAR INCISOR PLUS BLADE 2.92Cleared 510(K)
- K102686MYOSURE ROD LENS SCOPE SEALS2Cleared 510(K)
- K093218FEMEYE TWO2Cleared 510(K)
- K100559MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM2Cleared 510(K)
- K092421ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC2Cleared 510(K)
- K091838OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK2Cleared 510(K)
- K091100MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM2Cleared 510(K)
- K092278GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-42Cleared 510(K)
- K091465MYOSURE ROD LENS HYSTEROSCOPE2Cleared 510(K)
- K081070INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM2Cleared 510(K)
- K073690INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM2Cleared 510(K)
- K071127FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM2Cleared 510(K)
- K053583OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL2Cleared 510(K)
- K041774IUR RECIPROCATING MORCELLATOR MODEL # 72105172Cleared 510(K)
- K040390STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM2Cleared 510(K)
- K040302VERSAPOINT RESECTOSCOPIC SYSTEM2Cleared 510(K)
- K033113UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 87532Cleared 510(K)
- K031787SMITH & NEPHEW IUR MORCELLATION SYSTEM2Cleared 510(K)
- K031974ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-02Cleared 510(K)
- K022445VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V2Cleared 510(K)
- K022480ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC2Cleared 510(K)
- K012869GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.252Cleared 510(K)
- K013870SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 81052242Cleared 510(K)
- K003802HYSTEROSCOPES2Cleared 510(K)
- K001740KSEA MONOPOLAR VAPORIZATION ELECTRODES2Cleared 510(K)
- K000673HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.2412Cleared 510(K)
- K994418VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)2Cleared 510(K)
- K992901GYNECARE VERSAPOINT G-VAP ELECTRODE2Cleared 510(K)
- K993749GYRUS HYSTEROSCOPIC RESECTOSCOPE2Cleared 510(K)
- K991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C2Cleared 510(K)
- K992027KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR2Cleared 510(K)
- K990910MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS2Cleared 510(K)
- K990411MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE2Cleared 510(K)
- K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)2Cleared 510(K)
- K983901KSEA HF-SNARE2Cleared 510(K)
- K982771GYRUS HYSTEROSCOPIC RESECTOSCOPE2Cleared 510(K)
- K983569KSEA MONOPOLAR VAPORIZATION ELECTRODES2Cleared 510(K)
- K982659MEDIVISION HYSTEROSCOPE2Cleared 510(K)
- K980302WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES2Cleared 510(K)
- K981828GALILEO DISPOSABLE HYSTEROSCOPES2Cleared 510(K)
- K981800SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.6062Cleared 510(K)
- K971374GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE2Cleared 510(K)
- K974297GALILEO DISPOSABLE HYSTEROSCOPES2Cleared 510(K)
- K971420MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)2Cleared 510(K)
- K972426MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH2Cleared 510(K)
- K972210RESECTOSCOPE SAFETY SHEATH2Cleared 510(K)
- K971305FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM2Cleared 510(K)
- K962271ELECTROSURGICAL ELECRTRODES2Cleared 510(K)
- K971518KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES2Cleared 510(K)
- K971188SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS2Cleared 510(K)
- K954488ROLLER ELECTRODE2Cleared 510(K)
- K962256GALILEO HYSTEROSCOPES AND LAPAROSCOPES2Cleared 510(K)
- K961605KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE2Cleared 510(K)
- K962482SCUBA SYSTEM2Cleared 510(K)
- K961688MICROSPAN HYSTEROSCOPE2Cleared 510(K)
- K961506MICROSPAN HYSTEROSCOPE SHEATH2Cleared 510(K)
- K954648FEMRX OPERASTAR SYSTEM2Cleared 510(K)
- K954164HYSTEROSCOPE2Cleared 510(K)
- K952186HSW GMBH HYSTEROSCOPES & ACCESSORIES2Cleared 510(K)
- K955119SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES2Cleared 510(K)
- K951946HYSTEROSYS FLEXIBLE HYSTEROCOPE2Cleared 510(K)
- K940316HYSTERSCOPE2Cleared 510(K)
- K935716KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE2Cleared 510(K)
- K952032IMAGYN HYSTEROSCOPE SHEATHS2Cleared 510(K)
- K952779KARL STORZ FLEXIBLE HYSTERSCOPE2Cleared 510(K)
- K945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES2Cleared 510(K)
- K953109HAND EXTRACTOR HECTOR2Cleared 510(K)
- K950255ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM2Cleared 510(K)
- K952033IMAGYN HYSTEROSCOPE2Cleared 510(K)
- K933544FUJINON VIDEO LAPORASCOPE2Cleared 510(K)
- K950055A4722 OLYMPUS OPTICAL OBTURATOR2Cleared 510(K)
- K950036OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN2Cleared 510(K)
- K934286HYSTEROSCOPE2Cleared 510(K)
- K921942HYSTEROSCOPE (AND ACCESSORIES)2Cleared 510(K)
- K922420CONTINUOUS FLOW HYSTERO-RESECTOSCOPE2Cleared 510(K)
- K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES2Cleared 510(K)
- K922711FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE2Cleared 510(K)
- K924631CABOT MEDICAL UTERINE RESECTOSCOPE2Cleared 510(K)
- K931994RESECTOSCOPE SHEATH2Cleared 510(K)
- K914108RG27-SERIES RESECTOSCOPE AND ACCESSORIES2Cleared 510(K)
- K905392HT4-SERIES HYSTEROSCOPES AND ACCESSORIES2Cleared 510(K)
- K903146HYSTEROSCOPY SHEATH SET2Cleared 510(K)
- K895857CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY2Cleared 510(K)
- K897003OLYMPUS HYSTERORESECTOSCOPE2Cleared 510(K)
- K896917HYSTEROSCOPE2Cleared 510(K)
- K890328ADULT RESECTOSCOPE2Cleared 510(K)
- K892390FLEXIBLE IMMERSIBLE HYSTEROSCOPE2Cleared 510(K)
- K882270MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES2Cleared 510(K)
- K891451OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE2Cleared 510(K)
- K882761TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)2Cleared 510(K)
- K880314HYSTEROSCOPE AUTONOM 49922Cleared 510(K)
- K881249BAGGISH, HYSTEROSCOPE2Cleared 510(K)
- K841825SCOPE LIGHT2Cleared 510(K)
- K812202FIBER OPTIC LIGHT SOURCE2Cleared 510(K)
- K811270SCOPE MASTER2Cleared 510(K)
- K810569CONTACT-MICRO COLPOHYSTEROSCOPE2Cleared 510(K)
- K791330HYSTEROSER2Cleared 510(K)
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)1Product Code
- LHZViscometer, Mucus, Cervical1Product Code
- MKOFalloposcope2Product Code
- MOKVaginoscope And Accessories2Product Code
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic1Product Code
- NMHLaparoscope And Accessories, Gynecologic, Reprocessed2Product Code
- NMILaparoscopic Insufflator And Accessories, Reprocessed1Product Code
- NVTTubing And Tubing/Filter Fits1Product Code
- NWVLaparoscopic Accessories, Gynecologic1Product Code
- NWWHysteroscope Accessories1Product Code
- PCFSampler, Endocervical2Product Code
- OHDGynecological Laparoscopic Kit2Product Code
- OHEForensic Evidence Sexual Assault Kit2Product Code
- OHFCuldocentesis Kit2Product Code
- OHMCesarean Section Tray2Product Code
- OKXTrocar Kit2Product Code
- PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar2Product Code
- OKZEndometrial Sampling Kit2Product Code
- OSVInsufflator, Endoscopic Vessel Harvesting2Product Code
- PTZColposcope (And Colpomicroscope), Exempt2Product Code
- PVSFetal Blood Sampling Kit (Excludes Hiv Testing)2Product Code
- QHZSeal, Cervical, Mechanical, Unpowered1Product Code
- 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
- 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
Omni Hysteroscope, Omni Lok cervical seal
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191281
- 510(k) Type
- Traditional
- Applicant
- Hologic, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/29/2019
- Days to Decision
- 108 days
- Submission Type
- Summary