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
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
K
13
0087
PANPAC WORD/BARTHOLIN CATHETER
2
Cleared 510(K)
K
10
2141
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
2
Cleared 510(K)
K
09
3904
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
2
Cleared 510(K)
K
08
2939
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
2
Cleared 510(K)
K
06
2438
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
2
Cleared 510(K)
K
06
0289
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
2
Cleared 510(K)
K
01
3597
TAMPONADE UTERINE BALLOON CATHETER SET
2
Cleared 510(K)
K
01
4248
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
2
Cleared 510(K)
K
00
1590
DND 101
2
Cleared 510(K)
K
99
0738
DR. JAHANGER'S CUTTER
2
Cleared 510(K)
K
99
0045
BERACLAMP, MODEL BC-1
2
Cleared 510(K)
K
98
2464
SCC-23 SAFETY CLAMP AND CUTTER
2
Cleared 510(K)
K
98
0717
UROMED SLING KIT
2
Cleared 510(K)
K
98
0237
GYNEX ENDOSPECULUM
2
Cleared 510(K)
K
97
2013
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
2
Cleared 510(K)
K
97
1277
SAFE-T-CLAMP
2
Cleared 510(K)
K
95
2527
BALLOON UTERINE STENT
2
Cleared 510(K)
K
95
4619
CORDGUARD II
2
Cleared 510(K)
K
95
1081
OB/GYN PACKS
2
Cleared 510(K)
K
94
0907
MADDEN SURGICAL THIMBLE
2
Cleared 510(K)
K
94
1641
DISPOSABLE EMERGENCY OBSTETRICAL KIT
2
Cleared 510(K)
K
92
6532
ENDO CERVICAL CURETTE
2
Cleared 510(K)
K
93
0727
VARIOUS SCISSORS
2
Cleared 510(K)
K
93
0110
MICRO SURGERY NEEDLE HOLDERS
2
Cleared 510(K)
K
93
0031
MICRO SURGERY SCISSORS
2
Cleared 510(K)
K
92
6537
NEEDLE EXTENSIONS
2
Cleared 510(K)
K
92
6530
MIYA HOOK
2
Cleared 510(K)
K
92
6529
Z CLAMP SCISSORS
2
Cleared 510(K)
K
93
0032
RETRACTOR RODS
2
Cleared 510(K)
K
91
2075
C-SECTION TRAY
2
Cleared 510(K)
K
89
1398
RETRACTOR RODS
2
Cleared 510(K)
K
89
1399
CORSON MYOMA GRASPING FORCEPS
2
Cleared 510(K)
K
89
1397
GREENE-ARMYTAGE HEMOSTATIC FORCEPS
2
Cleared 510(K)
K
89
1046
SOPHER AND BIERER OVUM FORCEPS
2
Cleared 510(K)
K
89
1048
OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC
2
Cleared 510(K)
K
89
1045
MIYA HOOK
2
Cleared 510(K)
K
89
1042
MICRO SURGERY NEEDLE HOLDERS
2
Cleared 510(K)
K
89
1039
MICRO SURGERY FORCEPS
2
Cleared 510(K)
K
89
1040
MICRO SURGERY SCISSORS
2
Cleared 510(K)
K
88
4291
COOK HYSTEROCATH(TM)
2
Cleared 510(K)
K
88
0497
WORD BARTHOLIN GLAND CATHETER CODE: 1005
2
Cleared 510(K)
K
86
3439
INTRAUTERINE HEMOSTASIS BALLOON STENT
2
Cleared 510(K)
K
87
1069
MODIFIED HYSTEROSALPINGOGRAPY SET
2
Cleared 510(K)
K
86
4623
OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT
2
Cleared 510(K)
K
86
1385
MILEX BARTHOLIN GLAND CATHETER
2
Cleared 510(K)
K
84
4821
MICROINFERTILITY NEEDLE HOLDER, TITANIUM
2
Cleared 510(K)
K
84
4823
MICROINFERTILITY FORCEPS, TITANIUM
2
Cleared 510(K)
K
84
4822
MICROINFERTILITY SCISSORS, TITANIUM
2
Cleared 510(K)
K
84
2231
ACKRAD HYSTEROSALPINGOGRAPHY SET
2
Cleared 510(K)
K
81
0484
OVARY FORCEPS
2
Cleared 510(K)
K
81
0483
FALLOPIAN TUBE FORCEPS
2
Cleared 510(K)
K
79
2631
STERILIZATION PROCESS/DBL. GRIP CORD CLP
2
Cleared 510(K)
K
79
0852
VAGI-SPEC
2
Cleared 510(K)
K
79
0853
EASY-SPEC
2
Cleared 510(K)
K
79
0923
MI-MARK ENDOCERVICAL SAMPLING SET
2
Cleared 510(K)
K
78
0587
GYNESURG
2
Cleared 510(K)
K
77
0641
MINI-CONER TM
2
Cleared 510(K)
K
77
0727
MANIPULATOR & INJECTOR, UTERINE
2
Cleared 510(K)
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 20 December 2024 at 11:05 pm
OB
/
subpart-e—obstetrical-and-gynecological-surgical-devices
/
KNA
/
K891397
View Source
GREENE-ARMYTAGE HEMOSTATIC FORCEPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K891397
510(k) Type
Traditional
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/1989
Days to Decision
15 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
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
K
13
0087
PANPAC WORD/BARTHOLIN CATHETER
K
10
2141
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
K
09
3904
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
K
08
2939
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
K
06
2438
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
K
06
0289
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
K
01
3597
TAMPONADE UTERINE BALLOON CATHETER SET
K
01
4248
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
K
00
1590
DND 101
K
99
0738
DR. JAHANGER'S CUTTER
K
99
0045
BERACLAMP, MODEL BC-1
K
98
2464
SCC-23 SAFETY CLAMP AND CUTTER
K
98
0717
UROMED SLING KIT
K
98
0237
GYNEX ENDOSPECULUM
K
97
2013
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
K
97
1277
SAFE-T-CLAMP
K
95
2527
BALLOON UTERINE STENT
K
95
4619
CORDGUARD II
K
95
1081
OB/GYN PACKS
K
94
0907
MADDEN SURGICAL THIMBLE
K
94
1641
DISPOSABLE EMERGENCY OBSTETRICAL KIT
K
92
6532
ENDO CERVICAL CURETTE
K
93
0727
VARIOUS SCISSORS
K
93
0110
MICRO SURGERY NEEDLE HOLDERS
K
93
0031
MICRO SURGERY SCISSORS
K
92
6537
NEEDLE EXTENSIONS
K
92
6530
MIYA HOOK
K
92
6529
Z CLAMP SCISSORS
K
93
0032
RETRACTOR RODS
K
91
2075
C-SECTION TRAY
K
89
1398
RETRACTOR RODS
K
89
1399
CORSON MYOMA GRASPING FORCEPS
K
89
1397
GREENE-ARMYTAGE HEMOSTATIC FORCEPS
K
89
1046
SOPHER AND BIERER OVUM FORCEPS
K
89
1048
OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC
K
89
1045
MIYA HOOK
K
89
1042
MICRO SURGERY NEEDLE HOLDERS
K
89
1039
MICRO SURGERY FORCEPS
K
89
1040
MICRO SURGERY SCISSORS
K
88
4291
COOK HYSTEROCATH(TM)
K
88
0497
WORD BARTHOLIN GLAND CATHETER CODE: 1005
K
86
3439
INTRAUTERINE HEMOSTASIS BALLOON STENT
K
87
1069
MODIFIED HYSTEROSALPINGOGRAPY SET
K
86
4623
OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT
K
86
1385
MILEX BARTHOLIN GLAND CATHETER
K
84
4821
MICROINFERTILITY NEEDLE HOLDER, TITANIUM
K
84
4823
MICROINFERTILITY FORCEPS, TITANIUM
K
84
4822
MICROINFERTILITY SCISSORS, TITANIUM
K
84
2231
ACKRAD HYSTEROSALPINGOGRAPHY SET
K
81
0484
OVARY FORCEPS
K
81
0483
FALLOPIAN TUBE FORCEPS
K
79
2631
STERILIZATION PROCESS/DBL. GRIP CORD CLP
K
79
0852
VAGI-SPEC
K
79
0853
EASY-SPEC
K
79
0923
MI-MARK ENDOCERVICAL SAMPLING SET
K
78
0587
GYNESURG
K
77
0641
MINI-CONER TM
K
77
0727
MANIPULATOR & INJECTOR, UTERINE
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
/
KNA
/
K891397
View Source
GREENE-ARMYTAGE HEMOSTATIC FORCEPS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K891397
510(k) Type
Traditional
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/1989
Days to Decision
15 days