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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
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Subpart D—Prosthetic Devices
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CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
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FPX
Strip, Adhesive, Closure, Skin
1
Product Code
K
97
0441
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
1
Cleared 510(K)
K
95
2947
DELPORE SKIN CLOSURE
1
Cleared 510(K)
K
95
2702
DERMA SEAL
1
Cleared 510(K)
K
94
6321
BIOSTRIP STERILE WOUND CLOSURE STRIP
1
Cleared 510(K)
K
93
1005
DUKAL SKIN CLOSURE STRIP
1
Cleared 510(K)
K
92
1775
SPYROFLEX WOUND CLOSURES
1
Cleared 510(K)
K
89
4802
AWC BUTTERFLY WOUND CLOSURES
1
Cleared 510(K)
K
89
4205
TECNOL SILK STRIP
1
Cleared 510(K)
K
87
4813
OMED WOUND CLOSURE STRIPS
1
Cleared 510(K)
K
84
0945
SKIN CLOSURE
1
Cleared 510(K)
Show All 35 Submissions
FPY
Sheet, Burn
1
Product Code
KGX
Tape And Bandage, Adhesive
1
Product Code
KMF
Bandage, Liquid
1
Product Code
LRS
I.V. Start Kit
2
Product Code
MCY
Wound Dressing Kit
2
Product Code
MHW
Dressing, Compression
1
Product Code
NEC
Bandage, Liquid, Skin Protectant
1
Product Code
OXQ
Dressing Change Tray
1
Product Code
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
1
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FPX
/
K921775
View Source
SPYROFLEX WOUND CLOSURES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K921775
510(k) Type
Traditional
Applicant
POLYMINT INDUSTRIAL CO. LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/19/1992
Days to Decision
39 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
FPX
Strip, Adhesive, Closure, Skin
K
97
0441
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
K
95
2947
DELPORE SKIN CLOSURE
K
95
2702
DERMA SEAL
K
94
6321
BIOSTRIP STERILE WOUND CLOSURE STRIP
K
93
1005
DUKAL SKIN CLOSURE STRIP
K
92
1775
SPYROFLEX WOUND CLOSURES
K
89
4802
AWC BUTTERFLY WOUND CLOSURES
K
89
4205
TECNOL SILK STRIP
K
87
4813
OMED WOUND CLOSURE STRIPS
K
84
0945
SKIN CLOSURE
Show All 35 Submissions
FPY
Sheet, Burn
KGX
Tape And Bandage, Adhesive
KMF
Bandage, Liquid
LRS
I.V. Start Kit
MCY
Wound Dressing Kit
MHW
Dressing, Compression
NEC
Bandage, Liquid, Skin Protectant
OXQ
Dressing Change Tray
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FPX
/
K921775
View Source
SPYROFLEX WOUND CLOSURES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K921775
510(k) Type
Traditional
Applicant
POLYMINT INDUSTRIAL CO. LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/19/1992
Days to Decision
39 days
Submission Type
Statement