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
- K233043Smart Scope® CX2Cleared 510(K)
- K190187Gynescope System2Cleared 510(K)
- K182764Biop Digital Colposcope2Cleared 510(K)
- K181034Pocket Colposcope System2Cleared 510(K)
- K170446LT-300 SD Digital Video Colposcope2Cleared 510(K)
- K161871EVA (Enhanced Visual Assessment) System2Cleared 510(K)
- K160341Colposcope System2Cleared 510(K)
- K160380LT-300 HD2Cleared 510(K)
- K151878Video Colposcope2Cleared 510(K)
- K143119LT-300 Video Colposcope2Cleared 510(K)
- K140754COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM2Cleared 510(K)
- K132423THE GYNOCULAR2Cleared 510(K)
- K122311GC-3000E DIGITAL COLPOSCOPE2Cleared 510(K)
- K122973AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE2Cleared 510(K)
- K110147ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE2Cleared 510(K)
- K092433DYSIS2Cleared 510(K)
- K090324ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY2Cleared 510(K)
- K101141SEILER COLPOSCOPE, MODELS 935, 955 AND 9852Cleared 510(K)
- K100595ECLERIS MICROSTAR COLPOSCOPE2Cleared 510(K)
- K072691CERVICAL MD, MODEL C102Cleared 510(K)
- K073053COLPO-MASTER2Cleared 510(K)
- K070845SOUNMED COLOPOSCOPE COLPO-99/99PLUS2Cleared 510(K)
- K061306CO-1000 COLPOSCOPE, MULTIPLE2Cleared 510(K)
- K033870IMAGE MANAGEMENT SYSTEM2Cleared 510(K)
- K031436MEDISCOPE2Cleared 510(K)
- K031639INTERMED ZOOM COLPOSCOPE2Cleared 510(K)
- K021153GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-20002Cleared 510(K)
- K021854DFV CPG COLPOSCOPE2Cleared 510(K)
- K001314MEDSCOPE2Cleared 510(K)
- K000707LEICA COLPOSCOPE2Cleared 510(K)
- K992544TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM2Cleared 510(K)
- K981958LEISEGANG VIDEO COLPOSCOPE2Cleared 510(K)
- K972630COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM2Cleared 510(K)
- K963593IMT LOUPE-COLPOSCOPE2Cleared 510(K)
- K955635VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND2Cleared 510(K)
- K940094COLPOSCOPES AND ACCESSORIES2Cleared 510(K)
- K932896HM-0690 COLPOSCOPE2Cleared 510(K)
- K932782HM-06602Cleared 510(K)
- K913365ACCUSCOPE(TM) & ACCUSCOPE II(TM)2Cleared 510(K)
- K902313LM-1Z ZOOM SCOPE2Cleared 510(K)
- K903213ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 10022Cleared 510(K)
- K890387MALLEABLE PLACENTA CURETTE2Cleared 510(K)
- K884934JEDMED KP6 COLPOSCOPE2Cleared 510(K)
- K880195GYNESCOPE2Cleared 510(K)
- K871681PHOTOSTAR V-82Cleared 510(K)
- K871683COLPOSTAR V-62Cleared 510(K)
- K871682WALLACH CONVERTIBLE COLPOSCOPE2Cleared 510(K)
- K853389WALLACH ZOOM COLPOSCOPE2Cleared 510(K)
- K852980OCS-2 COLPOSCOPE2Cleared 510(K)
- K821616CERVISCOPE OPTICAL SYSTEM2Cleared 510(K)
- K801730KRYMED SYSTEM 4001 TILT SCOPE2Cleared 510(K)
- K791279KOLPOSKOP KP200052Cleared 510(K)
- K770896COLPOSCOPE MODEL II2Cleared 510(K)
- K770697COLPOSCOPE SYSTEM2Cleared 510(K)
- K761205DYNATECH JD7/JD7P COLPOSCOPE2Cleared 510(K)
- K760763COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I2Cleared 510(K)
- 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
- 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
THE GYNOCULAR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K132423
- 510(k) Type
- Traditional
- Applicant
- GYNIUS AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/8/2014
- Days to Decision
- 246 days
- Submission Type
- Summary