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
- K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)2Cleared 510(K)
- K210628X-FLO Fluid Management System2Cleared 510(K)
- K201355Endomat Select, IBS Shaver Software, License2Cleared 510(K)
- K180735Endomat Select2Cleared 510(K)
- K180825Fluent Fluid Management System2Cleared 510(K)
- K173489GYN-Pump PH3042Cleared 510(K)
- K172040Aquilex Fluid Control System AQL-100S2Cleared 510(K)
- K172048FluidSmart2Cleared 510(K)
- K133799THERMEDX FLUID MANAGMENT SYSTEM2Cleared 510(K)
- K123732HYSTEROSCOPY PUMP HM62Cleared 510(K)
- K112642AQUILEX FLUID CONTROL SYSTEM H1122Cleared 510(K)
- K110852DOLPHIN 3 FLUID MANAGEMENT SYSTEM2Cleared 510(K)
- K091939THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P20002Cleared 510(K)
- K031616IUR FLUID MANAGEMENT SYSTEM2Cleared 510(K)
- K031213AQUASENS FLUID MONITORING SYSTEM2Cleared 510(K)
- K022449HYSTEREOSCOPY PUMP HM42Cleared 510(K)
- K011876DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-22Cleared 510(K)
- K011069AQUASENS FLUID MONITORING SYSTEM2Cleared 510(K)
- K000806KARL STORZ HYSTEROMAT II2Cleared 510(K)
- K991799DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO2Cleared 510(K)
- K982867HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 00250002Cleared 510(K)
- K983889HYS-SURGIFLATOR 150P2Cleared 510(K)
- K970078HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM2Cleared 510(K)
- K971492AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR2Cleared 510(K)
- K964136HYSTERO CO2-PNEU 22212Cleared 510(K)
- K961091KARL STORZ MODEL 203020 20 EQUIMAT2Cleared 510(K)
- K934866HYS-SURGIMAT2Cleared 510(K)
- K933847HYS-SURGIFLATOR VP2Cleared 510(K)
- K950961KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP2Cleared 510(K)
- K941743CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP2Cleared 510(K)
- K924523HYS-SURGIFLATOR2Cleared 510(K)
- K936231THE KARL STORZ HAMOU ENDOMAT2Cleared 510(K)
- K933384BARD HYSTERO-FLO II PUMP2Cleared 510(K)
- K933873CONCEPT UNIVERSAL PUMP SYSTEM2Cleared 510(K)
- K921871HYSTEROMAT(TM) 37002Cleared 510(K)
- K930912HYSTEROMED 1002Cleared 510(K)
- K922632WOM HYSTEROFLATOR OP2Cleared 510(K)
- K9316067-510-25 HYSTEROMED TUBING KIT2Cleared 510(K)
- K922197INSUFFLATOR TUBING KIT2Cleared 510(K)
- K912498THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR2Cleared 510(K)
- K911844HYSTEROFLATOR 15002Cleared 510(K)
- K912789LM-100/200LOW FLOW INSUFFLATOR2Cleared 510(K)
- K905495HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR2Cleared 510(K)
- K905706GYN-1500 HYSTEROSCOPIC INUFFLATOR2Cleared 510(K)
- K901288DAVOL SCOPE IRRIGATION SYSTEM2Cleared 510(K)
- K900908CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 2002Cleared 510(K)
- K894259REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA2Cleared 510(K)
- K895659HUI MINI-FLEX2Cleared 510(K)
- K895907HYSTEROFLATOR 20012Cleared 510(K)
- K892001DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE2Cleared 510(K)
- K891028UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET2Cleared 510(K)
- K881680ACKRAD H/S PROCEDURE TRAY2Cleared 510(K)
- K873527DECHERNEY HYSTEROSCOPY PUMP SYSTEM2Cleared 510(K)
- K872860INSUFFLATOR TUBING2Cleared 510(K)
- K842943AXCAN UTERINE SUCCION INJECTOR2Cleared 510(K)
- 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
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K970078
- 510(k) Type
- Traditional
- Applicant
- DAVOL, INC., SUB. C.R. BARD, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/11/1997
- Days to Decision
- 336 days
- Submission Type
- Summary