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
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
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
K
96
2953
DEODORANT PANTY SHIELD
2
Cleared 510(K)
K
96
2962
DEODORANT PANTY LINER
2
Cleared 510(K)
K
96
2954
DEODORANT MAXI PAD
2
Cleared 510(K)
K
96
1119
CAREFREE PANTYLINERS
2
Cleared 510(K)
K
91
3238
ALWAYS, UNSCENTED MENSTRUAL PAD
2
Cleared 510(K)
K
91
3237
ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD
2
Cleared 510(K)
K
89
1473
TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO
2
Cleared 510(K)
K
89
0655
NEW FREEDOM THIN DEODORANT MAXI PADS
2
Cleared 510(K)
K
88
4951
TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT
2
Cleared 510(K)
K
88
4446
MAXITHINS SUPER PADS, DEODORANT
2
Cleared 510(K)
K
88
4445
MAXITHINS PANTY SHIELDS, DEODORANT
2
Cleared 510(K)
K
88
4444
MAXITHINS REGULAR PADS, DEODORANT
2
Cleared 510(K)
K
88
4429
ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD
2
Cleared 510(K)
K
88
2094
GARDS DEODORANT SANITARY NAPKIN
2
Cleared 510(K)
K
87
0066
KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS
2
Cleared 510(K)
K
86
4673
UNSCENTED MENSTRUAL PAD
2
Cleared 510(K)
K
86
4187
KOTEX (R) GOODNITES
2
Cleared 510(K)
K
86
2675
MODIFIED DEODORANT MAXITHINS PANTY SHIELDS
2
Cleared 510(K)
K
86
2678
MODIFIED REGULAR DEODORANT MAXITHINS PADS
2
Cleared 510(K)
K
86
2676
MODIFIED SUPER DEODORANT MAXITHINS PADS
2
Cleared 510(K)
K
86
2285
KOTEX LIGHTDAYS DEODORANT PANTILINERS
2
Cleared 510(K)
K
85
3000
SCENTED ALWAYS PANTILINERS
2
Cleared 510(K)
K
85
2225
BELIEVE DEODORANT LABIAL PADS
2
Cleared 510(K)
K
85
0956
ALWAYS MAXIPADS - SCENTED
2
Cleared 510(K)
K
85
0939
ALWAYS SUPER MAXIPAD-SCENTED
2
Cleared 510(K)
K
84
4975
SCENTED BREATHABLE MINI-SHIELD PRIVATE LABEL BRAND
2
Cleared 510(K)
K
84
3959
DEODORANT REGULAR MAXITHINS BODY-SHAPED MAXI PADS
2
Cleared 510(K)
K
84
3960
DEODORANT MAXITHINS BODY-SHAPED PANTY SHIELDS
2
Cleared 510(K)
K
84
3958
DEODORANT SUPER MAXITHINS BODY-SHAPED MAXI PADS
2
Cleared 510(K)
K
84
3886
SCENTED BREATHABLE PRIVATE LABEL MINI-SH
2
Cleared 510(K)
K
84
3155
SURE & NATURAL DEODORANT MAXI-SHIELD
2
Cleared 510(K)
K
84
1312
ASSURE-BREATHABLE PANTY LINERS/SCENT
2
Cleared 510(K)
K
84
2764
SCENTED MENSTRUAL PAD
2
Cleared 510(K)
K
83
4564
MENSTRUAL PADS
2
Cleared 510(K)
K
83
4302
STAYFREE* DEODORANT MAXI-PADS
2
Cleared 510(K)
K
83
4131
SCENTED MENSTRUAL PAD
2
Cleared 510(K)
K
83
2971
DEODORANT MAXITHINS PANTY SHIELD
2
Cleared 510(K)
K
83
2973
TAMPAX SUPER DEODORANT MAXITHINS
2
Cleared 510(K)
K
83
2972
REGULAR DEODORANT MAXITHINS PADS
2
Cleared 510(K)
K
83
2382
CAREFREE * PANTY SHIELDS-REG/DEOR
2
Cleared 510(K)
K
83
1691
PRIVATE LABEL DEODORANT MAXISHIELD
2
Cleared 510(K)
K
83
1693
MAXI PADS SCENTED DEODORIZED
2
Cleared 510(K)
K
83
0630
PRIVATE LABE/ DEODORANT MAXIPAD
2
Cleared 510(K)
K
83
0144
PANTY-LINERS SCENTED
2
Cleared 510(K)
K
82
3478
SCENTED MENSTRUAL PADS
2
Cleared 510(K)
K
82
1375
DEODORANT SURE & NATURAL MAXISHIELDS
2
Cleared 510(K)
K
81
2403
SCENTED MENSTRUAL PADS
2
Cleared 510(K)
K
81
1868
SCENTED MENSTRUAL PADS
2
Cleared 510(K)
K
80
2277
KOTEX LIGHTDAYS DEODORANT PANTILINERS
2
Cleared 510(K)
K
80
1024
ODOR MASKING AGENT IN BOUNDARY OBSTETRI.
2
Cleared 510(K)
K
80
1358
NEW FREEDOM ANYDAY PANTILINERS
2
Cleared 510(K)
K
79
2195
DEODORANT CAREFREE PANTY SHIELDS
2
Cleared 510(K)
K
79
1433
KOTEX LIGHTDAYS DEODORANT PATILINERS
2
Cleared 510(K)
K
78
2111
PADS, MINI, MAXI DEODORANT
2
Cleared 510(K)
K
77
1547
PETITES BETWEEN-PERIOD PROTECTORS
2
Cleared 510(K)
K
76
1233
STAYFREE MAXI PADS
2
Cleared 510(K)
K
76
0853
STAYFREE DEODORANT MINI-PADS
2
Cleared 510(K)
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 20 December 2024 at 11:05 pm
OB
/
subpart-f—obstetrical-and-gynecological-therapeutic-devices
/
HHL
/
K801358
View Source
NEW FREEDOM ANYDAY PANTILINERS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K801358
510(k) Type
Traditional
Applicant
KIMBERLY-CLARK CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/21/1980
Days to Decision
42 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
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
K
96
2953
DEODORANT PANTY SHIELD
K
96
2962
DEODORANT PANTY LINER
K
96
2954
DEODORANT MAXI PAD
K
96
1119
CAREFREE PANTYLINERS
K
91
3238
ALWAYS, UNSCENTED MENSTRUAL PAD
K
91
3237
ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD
K
89
1473
TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO
K
89
0655
NEW FREEDOM THIN DEODORANT MAXI PADS
K
88
4951
TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT
K
88
4446
MAXITHINS SUPER PADS, DEODORANT
K
88
4445
MAXITHINS PANTY SHIELDS, DEODORANT
K
88
4444
MAXITHINS REGULAR PADS, DEODORANT
K
88
4429
ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD
K
88
2094
GARDS DEODORANT SANITARY NAPKIN
K
87
0066
KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS
K
86
4673
UNSCENTED MENSTRUAL PAD
K
86
4187
KOTEX (R) GOODNITES
K
86
2675
MODIFIED DEODORANT MAXITHINS PANTY SHIELDS
K
86
2678
MODIFIED REGULAR DEODORANT MAXITHINS PADS
K
86
2676
MODIFIED SUPER DEODORANT MAXITHINS PADS
K
86
2285
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K
85
3000
SCENTED ALWAYS PANTILINERS
K
85
2225
BELIEVE DEODORANT LABIAL PADS
K
85
0956
ALWAYS MAXIPADS - SCENTED
K
85
0939
ALWAYS SUPER MAXIPAD-SCENTED
K
84
4975
SCENTED BREATHABLE MINI-SHIELD PRIVATE LABEL BRAND
K
84
3959
DEODORANT REGULAR MAXITHINS BODY-SHAPED MAXI PADS
K
84
3960
DEODORANT MAXITHINS BODY-SHAPED PANTY SHIELDS
K
84
3958
DEODORANT SUPER MAXITHINS BODY-SHAPED MAXI PADS
K
84
3886
SCENTED BREATHABLE PRIVATE LABEL MINI-SH
K
84
3155
SURE & NATURAL DEODORANT MAXI-SHIELD
K
84
1312
ASSURE-BREATHABLE PANTY LINERS/SCENT
K
84
2764
SCENTED MENSTRUAL PAD
K
83
4564
MENSTRUAL PADS
K
83
4302
STAYFREE* DEODORANT MAXI-PADS
K
83
4131
SCENTED MENSTRUAL PAD
K
83
2971
DEODORANT MAXITHINS PANTY SHIELD
K
83
2973
TAMPAX SUPER DEODORANT MAXITHINS
K
83
2972
REGULAR DEODORANT MAXITHINS PADS
K
83
2382
CAREFREE * PANTY SHIELDS-REG/DEOR
K
83
1691
PRIVATE LABEL DEODORANT MAXISHIELD
K
83
1693
MAXI PADS SCENTED DEODORIZED
K
83
0630
PRIVATE LABE/ DEODORANT MAXIPAD
K
83
0144
PANTY-LINERS SCENTED
K
82
3478
SCENTED MENSTRUAL PADS
K
82
1375
DEODORANT SURE & NATURAL MAXISHIELDS
K
81
2403
SCENTED MENSTRUAL PADS
K
81
1868
SCENTED MENSTRUAL PADS
K
80
2277
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K
80
1024
ODOR MASKING AGENT IN BOUNDARY OBSTETRI.
K
80
1358
NEW FREEDOM ANYDAY PANTILINERS
K
79
2195
DEODORANT CAREFREE PANTY SHIELDS
K
79
1433
KOTEX LIGHTDAYS DEODORANT PATILINERS
K
78
2111
PADS, MINI, MAXI DEODORANT
K
77
1547
PETITES BETWEEN-PERIOD PROTECTORS
K
76
1233
STAYFREE MAXI PADS
K
76
0853
STAYFREE DEODORANT MINI-PADS
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
/
HHL
/
K801358
View Source
NEW FREEDOM ANYDAY PANTILINERS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K801358
510(k) Type
Traditional
Applicant
KIMBERLY-CLARK CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/21/1980
Days to Decision
42 days