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
K
20
2915
IRIS Thermocoagulator and Digital Colposcope
2
Cleared 510(K)
K
15
2843
Liger Medical HTU-110
2
Cleared 510(K)
K
13
0606
FMWAND FERROMAGNETIC SURGICAL SYSTEM
2
Cleared 510(K)
K
12
1881
DOMAIN SURGICAL SYSTEM
2
Cleared 510(K)
K
07
0877
ENDOCERVICAL ELECTRODE # 2
2
Cleared 510(K)
K
06
1651
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
2
Cleared 510(K)
K
02
2593
THOMAS MEDICAL ELECTRODES
2
Cleared 510(K)
K
00
3608
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
2
Cleared 510(K)
K
00
2042
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
2
Cleared 510(K)
K
99
3527
LOOP ELECTRODE, BALL ELECTRODE
2
Cleared 510(K)
K
99
3777
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
2
Cleared 510(K)
K
98
3840
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
2
Cleared 510(K)
K
98
2739
GYNEX ELECTRODES
2
Cleared 510(K)
K
97
4138
ROCKET ELECTRODE
2
Cleared 510(K)
K
97
1986
VALLEY FORGE BIPOLAR LOOP
2
Cleared 510(K)
K
96
5245
TBD
2
Cleared 510(K)
K
96
3653
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
2
Cleared 510(K)
K
96
3348
WALLACH INTEGRATION UNIT
2
Cleared 510(K)
K
96
3852
KSEA THERMOCOAGULATOR (MODEL 265100 20)
2
Cleared 510(K)
K
95
5756
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
2
Cleared 510(K)
K
96
1460
LWEET CONE BIOPSY INSTRUMENT
2
Cleared 510(K)
K
95
2030
LOOP/SQUARE ELECTRODE
2
Cleared 510(K)
K
95
5093
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
2
Cleared 510(K)
K
95
2483
LEEP SYSTEM 1000
2
Cleared 510(K)
K
94
4450
SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
2
Cleared 510(K)
K
92
1791
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
2
Cleared 510(K)
K
94
2986
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
2
Cleared 510(K)
K
94
0191
ELECTROSURGICAL LOOP ELECTRODE
2
Cleared 510(K)
K
94
1251
FINESSE IEC/601
2
Cleared 510(K)
K
92
5333
SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
2
Cleared 510(K)
K
92
5560
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
2
Cleared 510(K)
K
93
5634
WALLACH LEEP PROCEDURE KIT
2
Cleared 510(K)
K
92
5478
ELECTROSURGICAL ELECTRODE
2
Cleared 510(K)
K
93
1541
MODEL 26-0375, ELECTROSURGICAL GENERATOR
2
Cleared 510(K)
K
93
1437
MODEL 80-1983, ELECTROSURGICAL GENERATOR
2
Cleared 510(K)
K
93
0132
LEEP AND LLETZ ELECTRODES
2
Cleared 510(K)
K
92
6179
SEDLACEK HANDLE
2
Cleared 510(K)
K
92
3570
CRYOMEDICS LLETZ LOOPS
2
Cleared 510(K)
K
92
3628
CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE
2
Cleared 510(K)
K
93
1338
16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
2
Cleared 510(K)
K
92
1386
SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
2
Cleared 510(K)
K
92
2206
SURGISTAT
2
Cleared 510(K)
K
92
1884
FORCE 2
2
Cleared 510(K)
K
92
1222
FORCE 1C
2
Cleared 510(K)
K
91
4367
ELECTROSURGICAL GENERATOR MODEL ESU100/250/550
2
Cleared 510(K)
K
91
4329
SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
2
Cleared 510(K)
K
91
2046
SINGLE USE LEE ELECTRODE
2
Cleared 510(K)
K
91
3213
SINGLE USE LEE ELECTRODE
2
Cleared 510(K)
K
90
5263
UTAH ESSU
2
Cleared 510(K)
K
90
5747
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR
2
Cleared 510(K)
K
89
5402
ENDOCOAGULATOR 2001 KLI
2
Cleared 510(K)
K
77
0295
ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
2
Cleared 510(K)
K
77
0292
MONITOR, FETAL HEART, MODEL 1980
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
HGI
/
K983840
View Source
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K983840
510(k) Type
Traditional
Applicant
WALLACH SURGICAL DEVICES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/20/1999
Days to Decision
202 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)
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)
K
20
2915
IRIS Thermocoagulator and Digital Colposcope
K
15
2843
Liger Medical HTU-110
K
13
0606
FMWAND FERROMAGNETIC SURGICAL SYSTEM
K
12
1881
DOMAIN SURGICAL SYSTEM
K
07
0877
ENDOCERVICAL ELECTRODE # 2
K
06
1651
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
K
02
2593
THOMAS MEDICAL ELECTRODES
K
00
3608
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
K
00
2042
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
K
99
3527
LOOP ELECTRODE, BALL ELECTRODE
K
99
3777
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
K
98
3840
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
K
98
2739
GYNEX ELECTRODES
K
97
4138
ROCKET ELECTRODE
K
97
1986
VALLEY FORGE BIPOLAR LOOP
K
96
5245
TBD
K
96
3653
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
K
96
3348
WALLACH INTEGRATION UNIT
K
96
3852
KSEA THERMOCOAGULATOR (MODEL 265100 20)
K
95
5756
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
K
96
1460
LWEET CONE BIOPSY INSTRUMENT
K
95
2030
LOOP/SQUARE ELECTRODE
K
95
5093
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
K
95
2483
LEEP SYSTEM 1000
K
94
4450
SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
K
92
1791
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
K
94
2986
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
K
94
0191
ELECTROSURGICAL LOOP ELECTRODE
K
94
1251
FINESSE IEC/601
K
92
5333
SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
K
92
5560
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
K
93
5634
WALLACH LEEP PROCEDURE KIT
K
92
5478
ELECTROSURGICAL ELECTRODE
K
93
1541
MODEL 26-0375, ELECTROSURGICAL GENERATOR
K
93
1437
MODEL 80-1983, ELECTROSURGICAL GENERATOR
K
93
0132
LEEP AND LLETZ ELECTRODES
K
92
6179
SEDLACEK HANDLE
K
92
3570
CRYOMEDICS LLETZ LOOPS
K
92
3628
CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE
K
93
1338
16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
K
92
1386
SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
K
92
2206
SURGISTAT
K
92
1884
FORCE 2
K
92
1222
FORCE 1C
K
91
4367
ELECTROSURGICAL GENERATOR MODEL ESU100/250/550
K
91
4329
SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
K
91
2046
SINGLE USE LEE ELECTRODE
K
91
3213
SINGLE USE LEE ELECTRODE
K
90
5263
UTAH ESSU
K
90
5747
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR
K
89
5402
ENDOCOAGULATOR 2001 KLI
K
77
0295
ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
K
77
0292
MONITOR, FETAL HEART, MODEL 1980
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
/
HGI
/
K983840
View Source
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K983840
510(k) Type
Traditional
Applicant
WALLACH SURGICAL DEVICES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/20/1999
Days to Decision
202 days
Submission Type
Summary