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
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
NGU
Balloon, Liver Tamponade
2
Product Code
EYR
Tourniquet, Gastro-Urology
1
Product Code
EXM
Truss, Umbilical
1
Product Code
EYN
Tray, Irrigation, Sterile
2
Product Code
K
94
4882
IRRIGATION TRAY
2
Cleared 510(K)
K
92
3939
IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER
2
Cleared 510(K)
K
92
3940
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
2
Cleared 510(K)
K
92
3941
IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
2
Cleared 510(K)
K
92
3938
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER
2
Cleared 510(K)
K
90
0148
KIT PAK IRRIGATION TRAY
2
Cleared 510(K)
K
90
0737
PISTON IRRIGATION TRAY
2
Cleared 510(K)
K
90
0736
BULB IRRIGATION TRAY
2
Cleared 510(K)
K
80
1783
CATHETER IRRIGATION TRAYS, #3300, 3310 &
2
Cleared 510(K)
K
79
2082
GAVAGE FEEDING SET
2
Cleared 510(K)
Show All 15 Submissions
FBQ
Trocar, Gastro-Urology
2
Product Code
FZG
Apparatus, Air Handling, Bench
2
Product Code
FZH
Apparatus, Air Handling, Room
2
Product Code
FZI
Apparatus, Air Handling, Enclosure
2
Product Code
GAX
Tourniquet, Nonpneumatic
1
Product Code
KCW
Epilator, High Frequency, Needle-Type
1
Product Code
KCX
Epilator, High Frequency, Tweezer-Type
1
Product Code
KCY
Tourniquet, Pneumatic
1
Product Code
KPJ
Chamber, Oxygen, Topical, Extremity
2
Product Code
OJS
Tourniquet Kit
1
Product Code
OLI
Fat Reducing Low Level Laser
2
Product Code
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
2
Product Code
QGX
General Use Pneumatic Tourniquet
1
Product Code
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-f—therapeutic-devices
/
EYN
/
K923940
View Source
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K923940
510(k) Type
Traditional
Applicant
AMERICAN HEALTHCARE CORP.
Country
United States
FDA Decision
Substantially Equivalent - Kit with Drugs
Decision Date
6/17/1993
Days to Decision
316 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
NGU
Balloon, Liver Tamponade
EYR
Tourniquet, Gastro-Urology
EXM
Truss, Umbilical
EYN
Tray, Irrigation, Sterile
K
94
4882
IRRIGATION TRAY
K
92
3939
IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER
K
92
3940
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
K
92
3941
IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
K
92
3938
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER
K
90
0148
KIT PAK IRRIGATION TRAY
K
90
0737
PISTON IRRIGATION TRAY
K
90
0736
BULB IRRIGATION TRAY
K
80
1783
CATHETER IRRIGATION TRAYS, #3300, 3310 &
K
79
2082
GAVAGE FEEDING SET
Show All 15 Submissions
FBQ
Trocar, Gastro-Urology
FZG
Apparatus, Air Handling, Bench
FZH
Apparatus, Air Handling, Room
FZI
Apparatus, Air Handling, Enclosure
GAX
Tourniquet, Nonpneumatic
KCW
Epilator, High Frequency, Needle-Type
KCX
Epilator, High Frequency, Tweezer-Type
KCY
Tourniquet, Pneumatic
KPJ
Chamber, Oxygen, Topical, Extremity
OJS
Tourniquet Kit
OLI
Fat Reducing Low Level Laser
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
QGX
General Use Pneumatic Tourniquet
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—therapeutic-devices
/
EYN
/
K923940
View Source
IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K923940
510(k) Type
Traditional
Applicant
AMERICAN HEALTHCARE CORP.
Country
United States
FDA Decision
Substantially Equivalent - Kit with Drugs
Decision Date
6/17/1993
Days to Decision
316 days
Submission Type
Statement