FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Miscellaneous
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
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
K
88
1507
ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES
2
Cleared 510(K)
K
87
1875
MODEL 5050 SURGILASER FOR OB-GYN USE
2
Cleared 510(K)
K
87
5314
GL-35 COLPOSCOPIC LASER SYSTEM
2
Cleared 510(K)
K
87
4615
LASER CANNISTER FILTER
2
Cleared 510(K)
K
88
0591
LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
2
Cleared 510(K)
K
88
0930
MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE
2
Cleared 510(K)
K
88
0991
LASER OPTICAL CATHETER SYSTEM
2
Cleared 510(K)
K
88
0173
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
2
Cleared 510(K)
K
87
4837
KTP/532 LASER FOR OB-GYN USE
2
Cleared 510(K)
K
87
5078
HERACURE LS 500
2
Cleared 510(K)
K
87
2709
MODEL 20-C, RL-20A/U, OB-10A/U
2
Cleared 510(K)
K
87
0841
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
2
Cleared 510(K)
K
86
4946
ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
2
Cleared 510(K)
K
87
2352
FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA
2
Cleared 510(K)
K
87
2254
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL
2
Cleared 510(K)
K
87
1579
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
2
Cleared 510(K)
K
87
2253
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
2
Cleared 510(K)
K
87
1220
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
2
Cleared 510(K)
K
87
0046
DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET
2
Cleared 510(K)
K
86
4378
CO2 LASER MICROMANIPULATOR
2
Cleared 510(K)
K
86
3221
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
2
Cleared 510(K)
K
86
3361
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
2
Cleared 510(K)
K
86
2861
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
2
Cleared 510(K)
K
86
3520
CO2 LASER MICROMANIPULATOR
2
Cleared 510(K)
K
86
2444
FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA
2
Cleared 510(K)
K
86
2228
CABOT LASER LAPAROSCOPY ACCESSORY SET
2
Cleared 510(K)
K
86
2227
MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
2
Cleared 510(K)
K
86
2456
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
2
Cleared 510(K)
K
86
1845
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
2
Cleared 510(K)
K
85
5093
MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
2
Cleared 510(K)
K
85
3903
ENDO-LASE CD40 CO2 FOR GYNECOLOGY
2
Cleared 510(K)
K
85
3876
ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
2
Cleared 510(K)
K
86
0329
FYODOROV RADIAL KERATOTOMY MARKER SET
2
Cleared 510(K)
K
85
4470
PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
2
Cleared 510(K)
K
85
4361
CO2 LASER LAPAROSCOPE SYSTEM
2
Cleared 510(K)
K
85
1425
MODEL J25-25 WATT CO2 LASER
2
Cleared 510(K)
K
85
2694
PORTALASE 200 CARBON SURGICAL LASER SYSTEM
2
Cleared 510(K)
K
84
4829
ABDOMINAL PRESSURE CONTROL VALVE
2
Cleared 510(K)
K
84
4431
YN CO2 LASER SYSTEM 30W
2
Cleared 510(K)
K
83
3528
CARBON DIOXIDE LASER ML 825
2
Cleared 510(K)
K
84
3515
MINUTEMAN CO2 MICROSURGICAL LASER GYN
2
Cleared 510(K)
K
82
0261
MONITOR CO2 LASER SYSTEM
2
Cleared 510(K)
K
81
0562
CARBON DIOXIDE (C02) MICROSURGICAL LASER
2
Cleared 510(K)
K
80
1197
CO2 LASER
2
Cleared 510(K)
K
80
0227
ML-800 CO2
2
Cleared 510(K)
K
78
2054
LASER, CO2 SURGICAL
2
Cleared 510(K)
K
77
2023
OB/GYN LASER, MODEL 920
2
Cleared 510(K)
K
76
1347
COLPOSCOPICALLY DIRECTED OB/GYN LASER
2
Cleared 510(K)
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 13 December 2024 at 11:05 pm
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
HHR
/
K862227
View Source
MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862227
510(k) Type
Traditional
Applicant
HGM, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/19/1986
Days to Decision
69 days
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)
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
K
88
1507
ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES
K
87
1875
MODEL 5050 SURGILASER FOR OB-GYN USE
K
87
5314
GL-35 COLPOSCOPIC LASER SYSTEM
K
87
4615
LASER CANNISTER FILTER
K
88
0591
LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
K
88
0930
MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE
K
88
0991
LASER OPTICAL CATHETER SYSTEM
K
88
0173
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
K
87
4837
KTP/532 LASER FOR OB-GYN USE
K
87
5078
HERACURE LS 500
K
87
2709
MODEL 20-C, RL-20A/U, OB-10A/U
K
87
0841
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
K
86
4946
ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
K
87
2352
FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA
K
87
2254
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL
K
87
1579
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K
87
2253
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
K
87
1220
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
K
87
0046
DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET
K
86
4378
CO2 LASER MICROMANIPULATOR
K
86
3221
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
K
86
3361
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
K
86
2861
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
K
86
3520
CO2 LASER MICROMANIPULATOR
K
86
2444
FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA
K
86
2228
CABOT LASER LAPAROSCOPY ACCESSORY SET
K
86
2227
MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
K
86
2456
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
K
86
1845
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
K
85
5093
MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
K
85
3903
ENDO-LASE CD40 CO2 FOR GYNECOLOGY
K
85
3876
ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
K
86
0329
FYODOROV RADIAL KERATOTOMY MARKER SET
K
85
4470
PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
K
85
4361
CO2 LASER LAPAROSCOPE SYSTEM
K
85
1425
MODEL J25-25 WATT CO2 LASER
K
85
2694
PORTALASE 200 CARBON SURGICAL LASER SYSTEM
K
84
4829
ABDOMINAL PRESSURE CONTROL VALVE
K
84
4431
YN CO2 LASER SYSTEM 30W
K
83
3528
CARBON DIOXIDE LASER ML 825
K
84
3515
MINUTEMAN CO2 MICROSURGICAL LASER GYN
K
82
0261
MONITOR CO2 LASER SYSTEM
K
81
0562
CARBON DIOXIDE (C02) MICROSURGICAL LASER
K
80
1197
CO2 LASER
K
80
0227
ML-800 CO2
K
78
2054
LASER, CO2 SURGICAL
K
77
2023
OB/GYN LASER, MODEL 920
K
76
1347
COLPOSCOPICALLY DIRECTED OB/GYN LASER
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
/
HHR
/
K862227
View Source
MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862227
510(k) Type
Traditional
Applicant
HGM, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/19/1986
Days to Decision
69 days