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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
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
HDO
Valve, Tubal Occlusion
3
Product Code
HDR
Cap, Cervical
2
Product Code
HDT
Device, Intrauterine, Contraceptive And Introducer
3
Product Code
HDW
Diaphragm, Contraceptive (And Accessories)
2
Product Code
HEB
Tampon, Menstrual, Unscented
2
Product Code
HEC
Insufflator, Vaginal
1
Product Code
HED
Douche Apparatus, Vaginal, Therapeutic
1
Product Code
HEE
Set, Anesthesia, Paracervical
2
Product Code
K
05
2365
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
2
Cleared 510(K)
K
02
1224
ENDOCERVICAL BLOCK NEEDLE
2
Cleared 510(K)
K
00
0117
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
2
Cleared 510(K)
K
98
3897
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
2
Cleared 510(K)
K
98
0238
GYNEX EXTENDED REACH NEEDLE
2
Cleared 510(K)
K
97
3671
ENDOCERVICAL BLOCK NEEDLE
2
Cleared 510(K)
K
95
4718
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
2
Cleared 510(K)
K
91
0253
LEEP REDIKIT
2
Cleared 510(K)
K
91
0252
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
2
Cleared 510(K)
HEG
Set, Anesthesia, Pudendal
2
Product Code
HEH
Chamber, Decompression, Abdominal
3
Product Code
HFY
Band, Tubal Occlusion
3
Product Code
HGB
Clip, Tubal Occlusion
3
Product Code
HGF
Source, Abortion Unit, Vacuum
2
Product Code
HGG
Controller, Abortion Unit, Vacuum
2
Product Code
HGH
Cannula, Suction, Uterine
2
Product Code
HGX
Pump, Breast, Powered
2
Product Code
HGY
Pump, Breast, Non-Powered
1
Product Code
HGZ
Heater, Perineal, Direct Contact
2
Product Code
HHA
Heater, Perineal, Radiant, Non-Contact
2
Product Code
HHD
Pad, Menstrual, Unscented
1
Product Code
HHE
Cup, Menstrual
2
Product Code
HHI
System, Abortion, Vacuum
2
Product Code
HHL
Pad, Menstrual, Scented
2
Product Code
HHQ
System, Abortion, Metreurynter-Balloon
3
Product Code
HHS
Transcervical Contraceptive Tubal Occlusion Device
3
Product Code
HII
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
3
Product Code
HIL
Tampon, Menstrual, Scented, Deodorized
2
Product Code
HIS
Condom
2
Product Code
KND
Heater, Perineal
2
Product Code
KNE
Set, Anesthesia, Obstetric
2
Product Code
KNH
Laparoscopic Contraceptive Tubal Occlusion Device
3
Product Code
KXQ
Vibrator For Therapeutic Use, Genital
2
Product Code
LTZ
Condom With Nonoxynol-9
2
Product Code
LZL
Micro-Condom
3
Product Code
MBU
Single-Use Internal Condom
2
Product Code
MFD
Cannula, Intrauterine Insemination
2
Product Code
NUR
Pad, Interlabial
1
Product Code
MOL
Condom, Synthetic
2
Product Code
MSC
Barrier, Std, Oral Sex
2
Product Code
NBV
Device, Engorgement, Clitoral
2
Product Code
NRC
Pads, Menstrual, Scented-Deodorized
1
Product Code
NUC
Lubricant, Personal
2
Product Code
NUQ
Pad, Menstrual, Reusable
1
Product Code
OBB
Kit, Conception-Assist, Home Use
2
Product Code
OBY
Condom, Female, Animal Tissue
3
Product Code
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
2
Product Code
OHH
Breast Pump Kit
2
Product Code
OKW
Seminal Fluid Collection Kit
2
Product Code
OOA
Hemorrhoid Prevention Pressure Wedge
2
Product Code
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
3
Product Code
PAI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
3
Product Code
PNU
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
2
Product Code
PVT
Maternity Kit
1
Product Code
PVU
Obstetrical Anesthesia Kit
2
Product Code
PVV
Paracervical Anesthesia Kit
2
Product Code
PVW
Pudendal Anesthesia Kit
2
Product Code
PWA
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
1
Product Code
PYT
Device, Fertility Diagnostic, Contraceptive, Software Application
2
Product Code
QPD
Personal Lubricant Ring
2
Product Code
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 30 November 2024 at 11:09 am
OB
/
subpart-f—obstetrical-and-gynecological-therapeutic-devices
/
HEE
/
K910253
View Source
LEEP REDIKIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910253
510(k) Type
Traditional
Applicant
COOPERSURGICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/18/1991
Days to Decision
86 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
Subpart F—Obstetrical and Gynecological Therapeutic Devices
HDO
Valve, Tubal Occlusion
HDR
Cap, Cervical
HDT
Device, Intrauterine, Contraceptive And Introducer
HDW
Diaphragm, Contraceptive (And Accessories)
HEB
Tampon, Menstrual, Unscented
HEC
Insufflator, Vaginal
HED
Douche Apparatus, Vaginal, Therapeutic
HEE
Set, Anesthesia, Paracervical
K
05
2365
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
K
02
1224
ENDOCERVICAL BLOCK NEEDLE
K
00
0117
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
K
98
3897
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
K
98
0238
GYNEX EXTENDED REACH NEEDLE
K
97
3671
ENDOCERVICAL BLOCK NEEDLE
K
95
4718
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
K
91
0253
LEEP REDIKIT
K
91
0252
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
HEG
Set, Anesthesia, Pudendal
HEH
Chamber, Decompression, Abdominal
HFY
Band, Tubal Occlusion
HGB
Clip, Tubal Occlusion
HGF
Source, Abortion Unit, Vacuum
HGG
Controller, Abortion Unit, Vacuum
HGH
Cannula, Suction, Uterine
HGX
Pump, Breast, Powered
HGY
Pump, Breast, Non-Powered
HGZ
Heater, Perineal, Direct Contact
HHA
Heater, Perineal, Radiant, Non-Contact
HHD
Pad, Menstrual, Unscented
HHE
Cup, Menstrual
HHI
System, Abortion, Vacuum
HHL
Pad, Menstrual, Scented
HHQ
System, Abortion, Metreurynter-Balloon
HHS
Transcervical Contraceptive Tubal Occlusion Device
HII
Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
HIL
Tampon, Menstrual, Scented, Deodorized
HIS
Condom
KND
Heater, Perineal
KNE
Set, Anesthesia, Obstetric
KNH
Laparoscopic Contraceptive Tubal Occlusion Device
KXQ
Vibrator For Therapeutic Use, Genital
LTZ
Condom With Nonoxynol-9
LZL
Micro-Condom
MBU
Single-Use Internal Condom
MFD
Cannula, Intrauterine Insemination
NUR
Pad, Interlabial
MOL
Condom, Synthetic
MSC
Barrier, Std, Oral Sex
NBV
Device, Engorgement, Clitoral
NRC
Pads, Menstrual, Scented-Deodorized
NUC
Lubricant, Personal
NUQ
Pad, Menstrual, Reusable
OBB
Kit, Conception-Assist, Home Use
OBY
Condom, Female, Animal Tissue
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
OHH
Breast Pump Kit
OKW
Seminal Fluid Collection Kit
OOA
Hemorrhoid Prevention Pressure Wedge
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PAI
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
PNU
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
PVT
Maternity Kit
PVU
Obstetrical Anesthesia Kit
PVV
Paracervical Anesthesia Kit
PVW
Pudendal Anesthesia Kit
PWA
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
PYT
Device, Fertility Diagnostic, Contraceptive, Software Application
QPD
Personal Lubricant Ring
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-f—obstetrical-and-gynecological-therapeutic-devices
/
HEE
/
K910253
View Source
LEEP REDIKIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910253
510(k) Type
Traditional
Applicant
COOPERSURGICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/18/1991
Days to Decision
86 days