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
- K182049exCellerator Cervical Collection Device2Cleared 510(K)
- K153128Kolplast Cervical Sample Collection Kit2Cleared 510(K)
- K141057DISPOSABLE CERVICAL BRUSH2Cleared 510(K)
- K111681HISTOBRUSH2Cleared 510(K)
- K083012PAPCONE2Cleared 510(K)
- K081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY2Cleared 510(K)
- K072381SOFTPAP CERVICAL CELL COLLECTOR2Cleared 510(K)
- K062433DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM2Cleared 510(K)
- K043369CERVEX-BRUSH COMBI2Cleared 510(K)
- K042527SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-91072Cleared 510(K)
- K041018DRG SOFTRELEASE2Cleared 510(K)
- K013258INPATH E2 COLLECTOR2Cleared 510(K)
- K002520ROVERS SPATULA2Cleared 510(K)
- K001119ROVERS ENDOCERVEX-BRUSH2Cleared 510(K)
- K991593ORIBRUSH - STANDARD - B0022Cleared 510(K)
- K991595ORIBRUSH - WITH PROTECTIVE TIP - B0012Cleared 510(K)
- K983202HARWILL MEDICAL CERVITULA CERVICAL SPATULA2Cleared 510(K)
- K983599SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT2Cleared 510(K)
- K983428SAFETEX CERVICAL SCRAPER (PLASTIC)2Cleared 510(K)
- K980356CERVICAL CYTOLOGY C-BRUSH MODEL CMB-10102Cleared 510(K)
- K971586DIGENE CERVICAL BRUSH2Cleared 510(K)
- K971849CYTOLOGY BRUSH2Cleared 510(K)
- K963801PAP BRUSH2Cleared 510(K)
- K963685EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER2Cleared 510(K)
- K961934PURITAN FOAM TIP SWAB MODEL 21972Cleared 510(K)
- K960469DETECT CYTOLOGY BRUSH II2Cleared 510(K)
- K954562GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT2Cleared 510(K)
- K950780AMSINO CERVICAL SCRAPER2Cleared 510(K)
- K941472CERVEX-BRUSH PAP KIT2Cleared 510(K)
- K933870VIBA-BRUSH2Cleared 510(K)
- K934732PELVIC EXAM TRAY2Cleared 510(K)
- K942843CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY2Cleared 510(K)
- K930955CERVEX-BRUSH2Cleared 510(K)
- K912325MICRO-PAP(TM) KIT2Cleared 510(K)
- K933628CYTOLOGY BRUSH2Cleared 510(K)
- K933415DETECT (TM) CYTOLOGY BRUSH2Cleared 510(K)
- K915844EXACT-TOUCH2Cleared 510(K)
- K911432ACCELLON CERVICAL BIOSAMPLER2Cleared 510(K)
- K923143CYTO PAK PAP SMEAR KIT2Cleared 510(K)
- K924908CELL COLLECTING BRUSH2Cleared 510(K)
- K911327CELL SWEEP2Cleared 510(K)
- K902995PC-BEADS POSTCOITAL TEST2Cleared 510(K)
- K902589CYTOSET(TM)2Cleared 510(K)
- K902591CYTETTE(TM) CYTOLOGY BRUSH2Cleared 510(K)
- K893229SPATULA FOR PAP SMEAR COLLECTION2Cleared 510(K)
- K896065WALLACH CC/BRUSH2Cleared 510(K)
- K895675PAP SMEAR TRAY2Cleared 510(K)
- K890848CERVEX-BRUSH2Cleared 510(K)
- K890706CYTOBRUSH2Cleared 510(K)
- K890013KOTEX SUPER MAXI PADS2Cleared 510(K)
- K891032ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG2Cleared 510(K)
- K890283CYTEX ONE AND CYTEX TWO2Cleared 510(K)
- K885274ROCKET ENDOCERVICAL BRUSH2Cleared 510(K)
- K884873CERVICAL BRUSH2Cleared 510(K)
- K884042ROCKET CERVICAL SPATULA2Cleared 510(K)
- K882628ENDO C BRUSH2Cleared 510(K)
- K881921C-E BRUSH2Cleared 510(K)
- K875162ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH2Cleared 510(K)
- K874604HISTOBRUSH2Cleared 510(K)
- K871552ORTHO* SPECIMEN COLLECTION CYTOBRUSH2Cleared 510(K)
- K870782CYCLO-BRUSH2Cleared 510(K)
- K870398PAP-PAK CYTOBRUSH KIT2Cleared 510(K)
- K864323CYTOLOGY BRUSHES2Cleared 510(K)
- K863145CERVICAL SCRAPERS2Cleared 510(K)
- K862322CHLAMYDIA KIT, STD KIT2Cleared 510(K)
- K862242PAP SMEAR KIT2Cleared 510(K)
- K861389PAP SMEAR KIT2Cleared 510(K)
- K851934CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA2Cleared 510(K)
- K850676SURGI-PAP KIT2Cleared 510(K)
- K832986PAP SMEAR BRUSH2Cleared 510(K)
- K811548CERVICAL SPATULA2Cleared 510(K)
- K802139SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY2Cleared 510(K)
- K761348CERVICAL-VAGINAL SPATULA2Cleared 510(K)
- 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
- 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
CYTOSET(TM)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K902589
- 510(k) Type
- Traditional
- Applicant
- BIRCHWOOD LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/10/1990
- Days to Decision
- 90 days