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
- K133857BRELLA-SPEC(TM) VAGINAL SPECULUM2Cleared 510(K)
- K132668IOB DISPOSABLE SPECULUM2Cleared 510(K)
- K130046CLEARSPEC SINGLE USE VAGINAL SPECULUM2Cleared 510(K)
- K120743SPECULUM, VAGINAL, NONMETAL2Cleared 510(K)
- K110766KOLPLUX SYSTEM2Cleared 510(K)
- K092870NON-STERILE DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM2Cleared 510(K)
- K072942MEDLINE DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K072762DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM2Cleared 510(K)
- K070964KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM2Cleared 510(K)
- K061339HIERSPEC SPECULUM2Cleared 510(K)
- K060129IGS VAGINAL SPECULUM2Cleared 510(K)
- K052420G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM2Cleared 510(K)
- K052192FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I2Cleared 510(K)
- K052912YUSHENG DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K052314DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE2Cleared 510(K)
- K050887GONGDONG DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K041757FEMSPEC DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K042950VAG O SPECULUM, MODELS VS1, VM1, VL12Cleared 510(K)
- K040817POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM2Cleared 510(K)
- K030693KENTEX DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K030761KAISHOU VAGINAL SPECULUM2Cleared 510(K)
- K022948VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L2Cleared 510(K)
- K021849TAGG DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K021676CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL2Cleared 510(K)
- K021017LEESPEC DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K020959GLO-SPEC I, II AND III2Cleared 510(K)
- K020726DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE2Cleared 510(K)
- K012535DRG DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K013835GLOBAL HEALTHCARE VAGINAL SPECULUM2Cleared 510(K)
- K013817GLO-SPEC2Cleared 510(K)
- K012859NU-SPEC D2Cleared 510(K)
- K002912VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 6000732Cleared 510(K)
- K003540(DISPOSABLE) VAGINAL SPECULUM2Cleared 510(K)
- K000444MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM2Cleared 510(K)
- K000414MEDISUL DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K992736WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM2Cleared 510(K)
- K991963PATTON SPECULUM2Cleared 510(K)
- K991827GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 7200432Cleared 510(K)
- K984211MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 3032Cleared 510(K)
- K983716VITALCARE DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K973853KOLPLAST VAGINAL SPECULUM2Cleared 510(K)
- K974228HOSPITAL'S SPEC2Cleared 510(K)
- K971979PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS2Cleared 510(K)
- K925501NYLON COATED SPECULA2Cleared 510(K)
- K963377EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC2Cleared 510(K)
- K951898VERSA-VU2Cleared 510(K)
- K951528AMSINO DISPOSABLE VIGINAL SPECULUM2Cleared 510(K)
- K941272KLEENSPEC2Cleared 510(K)
- K930954THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV2Cleared 510(K)
- K922154INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION2Cleared 510(K)
- K935636GRAVESPEC2Cleared 510(K)
- K933521SPECULUM2Cleared 510(K)
- K926536DISPOSABLE PLASTIC VAGINAL SPECULA2Cleared 510(K)
- K920803HSG TRAY2Cleared 510(K)
- K903080DISPOSABLE PLASTIC VAGINAL SPECULUM2Cleared 510(K)
- K903744PHYSICIAN'S CHOICE2Cleared 510(K)
- K894957DISPOSABLE PLASTIC VAGINAL SPECULA2Cleared 510(K)
- K894489GYNECOLOGIC EXAMINATION KIT2Cleared 510(K)
- K880587AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #32Cleared 510(K)
- K880586AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #22Cleared 510(K)
- K880588AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #42Cleared 510(K)
- K882605EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM2Cleared 510(K)
- K863274MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM2Cleared 510(K)
- K863275MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM2Cleared 510(K)
- K842014HOSPITAL'S-SPEC2Cleared 510(K)
- K841909VAGINAL SPECULUM - DISPOSABLE2Cleared 510(K)
- K841867KIDD VAGINAL SPECULUM2Cleared 510(K)
- K830725GENT-L-SPEC DISPOS. VAGINAL SPECULUM2Cleared 510(K)
- K822086DIA-SPEC2Cleared 510(K)
- K822084PRO-SPEC2Cleared 510(K)
- 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
PRO-SPEC
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K822084
- 510(k) Type
- Traditional
- Applicant
- EXITEC, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/19/1982
- Days to Decision
- 37 days