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
- K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)2Cleared 510(K)
- K201952CrossGlide ETS Plus2Cleared 510(K)
- K192534CrossBay Endometrial Tissue Sampler (ETS)2Cleared 510(K)
- K102847DISPOSABLE ENDOMETRIAL SUCTION CURETTE2Cleared 510(K)
- K092982THE PANPAC SUCTION CURETTE2Cleared 510(K)
- K051294FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-12Cleared 510(K)
- K040189ENDOMETRIAL SAMPLING SYRINGE2Cleared 510(K)
- K021876MAS WITH OR WITHOUT SYRINGE2Cleared 510(K)
- K020628CURELLE, PREFERRED CURELLE, CUTEQ 2.52Cleared 510(K)
- K001555SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 262Cleared 510(K)
- K001545PIPET CURET2Cleared 510(K)
- K000974FOWLER ENDOCURETTE, MODEL CUR-XXX2Cleared 510(K)
- K000026APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER2Cleared 510(K)
- K992926GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)2Cleared 510(K)
- K991895RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)2Cleared 510(K)
- K990387ENDOMETRIAL SAMPLER2Cleared 510(K)
- K974819SELECTCELLS(TM) MINI2Cleared 510(K)
- K960239CPR D & C TRAY2Cleared 510(K)
- K954097SELECTCELLS STANDARD2Cleared 510(K)
- K952652MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER2Cleared 510(K)
- K915491CURELLE2Cleared 510(K)
- K914241PIONEER PRO-PUMP DUAL CONTROL2Cleared 510(K)
- K914220PIONEER PRO-PUMP2Cleared 510(K)
- K881456PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE2Cleared 510(K)
- K875084CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE2Cleared 510(K)
- K872908ENDOMETRIAL SAMPLER2Cleared 510(K)
- K853216MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,42Cleared 510(K)
- K854415ENDOMETRIAL PIPELLE2Cleared 510(K)
- K823080VAKUTAGE2Cleared 510(K)
- K823006MEDEVICES ASPIRATION HOSE2Cleared 510(K)
- K822382U.V.A.C. HANDLER SET2Cleared 510(K)
- K812426UTERINE ASPIRATION CURETTES(RIGID&FLEX)2Cleared 510(K)
- K803210MENSTRUAL ASPIRATION KITS2Cleared 510(K)
- K801070SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES2Cleared 510(K)
- K791765MASTERSON* ENDOMETRIAL BIOPSY KIT2Cleared 510(K)
- K790875MONOJECT ENDOMETRIAL SAMPLING KIT2Cleared 510(K)
- K781830BIOPSY KIT 781101, ASPIRATION2Cleared 510(K)
- K772121ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.2Cleared 510(K)
- K771149ENDOMETRIAL ASPIRATION BIOSPY KIT 1823412Cleared 510(K)
- K770674CURETTE, UTERINE, VACUUM ASPIRATING2Cleared 510(K)
- K760264CURETTE, PROPOSED TIS-U-TRAP, METAL2Cleared 510(K)
- 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
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K853216
- 510(k) Type
- Traditional
- Applicant
- GYNECO, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/2/1986
- Days to Decision
- 244 days