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Innolitics
Anesthesiology
Review Panel
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Review Panel
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Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
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Neurology
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Ophthalmic
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Pathology
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Radiology
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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
FBQ
Trocar, Gastro-Urology
2
Product Code
K
01
2198
GIBBONS STERILE TROCAR KITS
2
Cleared 510(K)
K
98
0804
SABRE BT BLUNT0TIP SURGICAL TROCAR
2
Cleared 510(K)
K
94
4640
LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT
2
Cleared 510(K)
K
94
4104
GABRIS LAPAROSCOPIC SURGICAL KITS
2
Cleared 510(K)
K
94
2885
AUTO SUTURE MODIFIED GRIP
2
Cleared 510(K)
K
93
4724
AESCULAP TROCAR INSTRUMENT SET
2
Cleared 510(K)
K
90
4638
TROCAR DISPOSABLE
2
Cleared 510(K)
K
90
0123
AUTO SUTURE SURGIPORT SPIRAL SLEEVE
2
Cleared 510(K)
K
84
1716
ENDOPORT EROCAR
2
Cleared 510(K)
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
/
FBQ
/
K980804
View Source
SABRE BT BLUNT0TIP SURGICAL TROCAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K980804
510(k) Type
Traditional
Applicant
ENDOSCOPIC CONCEPTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/1/1998
Days to Decision
30 days
Submission Type
Summary
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
FBQ
Trocar, Gastro-Urology
K
01
2198
GIBBONS STERILE TROCAR KITS
K
98
0804
SABRE BT BLUNT0TIP SURGICAL TROCAR
K
94
4640
LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT
K
94
4104
GABRIS LAPAROSCOPIC SURGICAL KITS
K
94
2885
AUTO SUTURE MODIFIED GRIP
K
93
4724
AESCULAP TROCAR INSTRUMENT SET
K
90
4638
TROCAR DISPOSABLE
K
90
0123
AUTO SUTURE SURGIPORT SPIRAL SLEEVE
K
84
1716
ENDOPORT EROCAR
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
/
FBQ
/
K980804
View Source
SABRE BT BLUNT0TIP SURGICAL TROCAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K980804
510(k) Type
Traditional
Applicant
ENDOSCOPIC CONCEPTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/1/1998
Days to Decision
30 days
Submission Type
Summary