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Innolitics
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
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Neurology
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Review Panel
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Review Panel
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Review Panel
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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
GCI
Laryngoscope, Endoscope
2
Product Code
GCJ
Laparoscope, General & Plastic Surgery
2
Product Code
MFJ
Device, Endoscopic Suturing
2
Product Code
EPY
Speculum, Ent
1
Product Code
NAY
System, Surgical, Computer Controlled Instrument
2
Product Code
NEQ
Device, Telemedicine, Robotic
2
Product Code
PDT
Burn Resuscitation Decision Support Software
2
Product Code
FDP
Apparatus, Pneumoperitoneum, Automatic
2
Product Code
GCG
Peritoneoscope
2
Product Code
GCH
Mediastinoscope, Diagnostic
2
Product Code
OTJ
Laparoscopic Single Port Access Device
2
Product Code
K
23
2062
Uni-port
2
Cleared 510(K)
K
22
0081
CORE-SPORT
2
Cleared 510(K)
K
20
2688
AFS Medical Sterile Single-Use Access Port System
2
Cleared 510(K)
K
16
0797
FMX314 Surgical Platform
2
Cleared 510(K)
K
15
2598
Endo Keeper
2
Cleared 510(K)
K
12
1309
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
2
Cleared 510(K)
K
12
0898
KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
2
Cleared 510(K)
K
11
1407
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
2
Cleared 510(K)
K
11
2196
OCTOTMPORT
2
Cleared 510(K)
K
11
0004
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
2
Cleared 510(K)
Show All 11 Submissions
OWN
Confocal Optical Imaging
2
Product Code
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
2
Product Code
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
2
Product Code
POY
Post Breast Biopsy Hemostatic Breast Compression Device
2
Product Code
FXE
Speculum, Non-Illuminated
1
Product Code
FXF
Speculum, Illuminated
1
Product Code
FXG
Specula Accessories
1
Product Code
JYK
Holder, Ear Speculum
1
Product Code
KAG
Holder, Speculum, Ent
1
Product Code
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
2
Product Code
QZB
Software Controlled Endoscope And Instrument Holder
2
Product Code
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
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-b—diagnostic-devices
/
OTJ
/
K112196
View Source
OCTOTMPORT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
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
GCI
Laryngoscope, Endoscope
GCJ
Laparoscope, General & Plastic Surgery
MFJ
Device, Endoscopic Suturing
EPY
Speculum, Ent
NAY
System, Surgical, Computer Controlled Instrument
NEQ
Device, Telemedicine, Robotic
PDT
Burn Resuscitation Decision Support Software
FDP
Apparatus, Pneumoperitoneum, Automatic
GCG
Peritoneoscope
GCH
Mediastinoscope, Diagnostic
OTJ
Laparoscopic Single Port Access Device
K
23
2062
Uni-port
K
22
0081
CORE-SPORT
K
20
2688
AFS Medical Sterile Single-Use Access Port System
K
16
0797
FMX314 Surgical Platform
K
15
2598
Endo Keeper
K
12
1309
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
K
12
0898
KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
K
11
1407
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
K
11
2196
OCTOTMPORT
K
11
0004
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
Show All 11 Submissions
OWN
Confocal Optical Imaging
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
POY
Post Breast Biopsy Hemostatic Breast Compression Device
FXE
Speculum, Non-Illuminated
FXF
Speculum, Illuminated
FXG
Specula Accessories
JYK
Holder, Ear Speculum
KAG
Holder, Speculum, Ent
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
QZB
Software Controlled Endoscope And Instrument Holder
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
Toxicology
Medical Genetics
Unknown
SU
/
subpart-b—diagnostic-devices
/
OTJ
/
K112196
View Source
OCTOTMPORT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...