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Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
HER
Pelvimeter, External
1
Product Code
FHG
Bell, Circumcision
2
Product Code
FHJ
Shield, Circumcision
2
Product Code
HCY
Curette, Uterine
1
Product Code
HCZ
Forceps, Surgical, Gynecological
2
Product Code
HDA
Forceps, Obstetrical
2
Product Code
HDB
Extractor, Vacuum, Fetal
2
Product Code
HDC
Tenaculum, Uterine
2
Product Code
HDD
Table, Obstetrical, Ac-Powered (And Accessories)
2
Product Code
HDE
Hook, Fibroid, Gynecological
1
Product Code
HDF
Speculum, Vaginal, Metal
1
Product Code
HDG
Speculum, Vaginal, Metal, Fiberoptic
1
Product Code
HDH
Needle, Cerclage, Gynecological
1
Product Code
HDI
Hook, Destructive, Obstetrical
2
Product Code
HDJ
Scissors, Umbilical
1
Product Code
HDK
Scissors, Episiotomy
1
Product Code
HDL
Retractor, Vaginal
1
Product Code
HDM
Packer, Uterine
1
Product Code
HDN
Dilator, Cervical, Expandable
3
Product Code
HDP
Elevator, Uterine
2
Product Code
HDQ
Dilator, Cervical, Fixed Size
1
Product Code
HDY
Dilator, Cervical, Hygroscopic-Laminaria
2
Product Code
HDZ
Knife, Cervical Cone
2
Product Code
HFB
Forceps, Biopsy, Gynecological
1
Product Code
HFG
Coagulator, Laparoscopic, Unipolar (And Accessories)
2
Product Code
K
18
1124
Acessa ProVu System
2
Cleared 510(K)
K
13
2744
ACESSA GUIDANCE SYSTEM
2
Cleared 510(K)
K
13
2184
ACESSA GUIDANCE HANDPIECE
2
Cleared 510(K)
K
12
1858
THE ABLATION SYSTEM
2
Cleared 510(K)
K
10
1606
MICROMED PD-8K INSULATION DEFECT DETECTOR
2
Cleared 510(K)
K
99
1424
INSULSCAN INSULATION TESTING SYSTEM
2
Cleared 510(K)
K
96
1695
ENDO-TECH LTD., TIPS
2
Cleared 510(K)
K
92
1405
DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP
2
Cleared 510(K)
K
91
5406
DAVOL ELECTROSUGICAL PROBES
2
Cleared 510(K)
K
90
4240
SINGLE USE LAPARSCOPIC ELECTRODE
2
Cleared 510(K)
Show All 11 Submissions
HFH
Coagulator, Hysteroscopic (And Accessories)
2
Product Code
HFI
Coagulator, Culdoscopic (And Accessories)
2
Product Code
HFW
Clamp, Umbilical
2
Product Code
HFX
Clamp, Circumcision
2
Product Code
HFZ
Craniotribe
2
Product Code
HGA
Cranioclast
2
Product Code
HGC
Clamp, Uterine
1
Product Code
HGD
Applicator, Vaginal
1
Product Code
HGE
Amniotome
1
Product Code
HGI
Electrocautery, Gynecologic (And Accessories)
2
Product Code
HHF
Remover, Intrauterine Device, Contraceptive, Hook-Type
1
Product Code
HHG
Dilator, Cervical, Vibratory
3
Product Code
HHM
Sound, Uterine
1
Product Code
HHN
Cleidoclast
2
Product Code
HHO
Screw, Fibroid, Gynecological
2
Product Code
HHP
Table, Obstetrical, Manual (And Accessories)
2
Product Code
HHR
Laser, Surgical, Gynecologic
2
Product Code
HHT
Spatula, Cervical, Cytological
2
Product Code
HIB
Speculum, Vaginal, Nonmetal
2
Product Code
HIC
Speculum, Vaginal, Nonmetal, Fiberoptic
2
Product Code
HIM
Electrocautery, Endoscopic And Accessories
2
Product Code
HIN
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
2
Product Code
KNA
Instrument, Manual, Specialized Obstetric-Gynecologic
2
Product Code
KNB
Instrument, Destructive, Fetal, Obstetric
2
Product Code
KNC
Table, Obstetric (And Accessories)
2
Product Code
KNF
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
2
Product Code
KOH
Instrument, Manual, General Obstetric-Gynecologic
1
Product Code
LBX
Pelvimeter, Internal
2
Product Code
LKF
Cannula, Manipulator/Injector, Uterine
2
Product Code
LLW
Laser, Neodymium:Yag For Gynecologic Use
2
Product Code
MDG
System, Intrafallopian Cannula
2
Product Code
MLS
Labor And Delivery Kit
2
Product Code
MLT
Pelvic Exam Kit
2
Product Code
MOV
Catheters, Salpingography
2
Product Code
MPU
Source, Chemiluminescent Light
2
Product Code
NBZ
Clamp And Cutter, Umbilical
2
Product Code
NMG
Forceps, Biopsy, Gynecological, Reprocessed
2
Product Code
OHC
Obstetrical Vacuum Delivery Kit
2
Product Code
PBQ
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
2
Product Code
OHG
Circumcision Tray
2
Product Code
PFJ
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
2
Product Code
OHL
Pap Smear Kit
2
Product Code
OJF
Hysterectomy Kit
2
Product Code
PGK
Cannula, Injector, Uterine, Endometrial Biopsy
2
Product Code
PKN
Dilator, Cervical, Synthetic, Osmotic
2
Product Code
OKU
Emergency Obstetrical Kit
1
Product Code
OKV
Obstetrical Kit
2
Product Code
OKY
Cytology Kit
2
Product Code
OQY
Intrauterine Tamponade Balloon
2
Product Code
PMU
Containment System, Laparoscopic Power Morcellation, With Instrument Port
2
Product Code
PON
Catheter, Balloon, Dilation Of Cervical Canal
2
Product Code
PUA
Tenaculum, Uterine, Exempt
2
Product Code
PVR
D&C Tray
2
Product Code
PVX
Vaginal Examination Tray
2
Product Code
PWB
Fetal Head Elevator
2
Product Code
PWI
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
2
Product Code
PWK
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
2
Product Code
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
HFG
/
K181124
View Source
Acessa ProVu System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181124
510(k) Type
Traditional
Applicant
Acessa Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/28/2018
Days to Decision
151 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
HER
Pelvimeter, External
FHG
Bell, Circumcision
FHJ
Shield, Circumcision
HCY
Curette, Uterine
HCZ
Forceps, Surgical, Gynecological
HDA
Forceps, Obstetrical
HDB
Extractor, Vacuum, Fetal
HDC
Tenaculum, Uterine
HDD
Table, Obstetrical, Ac-Powered (And Accessories)
HDE
Hook, Fibroid, Gynecological
HDF
Speculum, Vaginal, Metal
HDG
Speculum, Vaginal, Metal, Fiberoptic
HDH
Needle, Cerclage, Gynecological
HDI
Hook, Destructive, Obstetrical
HDJ
Scissors, Umbilical
HDK
Scissors, Episiotomy
HDL
Retractor, Vaginal
HDM
Packer, Uterine
HDN
Dilator, Cervical, Expandable
HDP
Elevator, Uterine
HDQ
Dilator, Cervical, Fixed Size
HDY
Dilator, Cervical, Hygroscopic-Laminaria
HDZ
Knife, Cervical Cone
HFB
Forceps, Biopsy, Gynecological
HFG
Coagulator, Laparoscopic, Unipolar (And Accessories)
K
18
1124
Acessa ProVu System
K
13
2744
ACESSA GUIDANCE SYSTEM
K
13
2184
ACESSA GUIDANCE HANDPIECE
K
12
1858
THE ABLATION SYSTEM
K
10
1606
MICROMED PD-8K INSULATION DEFECT DETECTOR
K
99
1424
INSULSCAN INSULATION TESTING SYSTEM
K
96
1695
ENDO-TECH LTD., TIPS
K
92
1405
DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP
K
91
5406
DAVOL ELECTROSUGICAL PROBES
K
90
4240
SINGLE USE LAPARSCOPIC ELECTRODE
Show All 11 Submissions
HFH
Coagulator, Hysteroscopic (And Accessories)
HFI
Coagulator, Culdoscopic (And Accessories)
HFW
Clamp, Umbilical
HFX
Clamp, Circumcision
HFZ
Craniotribe
HGA
Cranioclast
HGC
Clamp, Uterine
HGD
Applicator, Vaginal
HGE
Amniotome
HGI
Electrocautery, Gynecologic (And Accessories)
HHF
Remover, Intrauterine Device, Contraceptive, Hook-Type
HHG
Dilator, Cervical, Vibratory
HHM
Sound, Uterine
HHN
Cleidoclast
HHO
Screw, Fibroid, Gynecological
HHP
Table, Obstetrical, Manual (And Accessories)
HHR
Laser, Surgical, Gynecologic
HHT
Spatula, Cervical, Cytological
HIB
Speculum, Vaginal, Nonmetal
HIC
Speculum, Vaginal, Nonmetal, Fiberoptic
HIM
Electrocautery, Endoscopic And Accessories
HIN
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
KNA
Instrument, Manual, Specialized Obstetric-Gynecologic
KNB
Instrument, Destructive, Fetal, Obstetric
KNC
Table, Obstetric (And Accessories)
KNF
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
KOH
Instrument, Manual, General Obstetric-Gynecologic
LBX
Pelvimeter, Internal
LKF
Cannula, Manipulator/Injector, Uterine
LLW
Laser, Neodymium:Yag For Gynecologic Use
MDG
System, Intrafallopian Cannula
MLS
Labor And Delivery Kit
MLT
Pelvic Exam Kit
MOV
Catheters, Salpingography
MPU
Source, Chemiluminescent Light
NBZ
Clamp And Cutter, Umbilical
NMG
Forceps, Biopsy, Gynecological, Reprocessed
OHC
Obstetrical Vacuum Delivery Kit
PBQ
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
OHG
Circumcision Tray
PFJ
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
OHL
Pap Smear Kit
OJF
Hysterectomy Kit
PGK
Cannula, Injector, Uterine, Endometrial Biopsy
PKN
Dilator, Cervical, Synthetic, Osmotic
OKU
Emergency Obstetrical Kit
OKV
Obstetrical Kit
OKY
Cytology Kit
OQY
Intrauterine Tamponade Balloon
PMU
Containment System, Laparoscopic Power Morcellation, With Instrument Port
PON
Catheter, Balloon, Dilation Of Cervical Canal
PUA
Tenaculum, Uterine, Exempt
PVR
D&C Tray
PVX
Vaginal Examination Tray
PWB
Fetal Head Elevator
PWI
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
PWK
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
HFG
/
K181124
View Source
Acessa ProVu System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181124
510(k) Type
Traditional
Applicant
Acessa Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/28/2018
Days to Decision
151 days
Submission Type
Summary