We're working on improving this tool, so please
email us
suggestions.
Sign up
for email updates to learn about new features.
✕
FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Biological Stains
CFR Sub-Part
Clinical Chemistry Test Systems
CFR Sub-Part
Clinical Laboratory Instruments
CFR Sub-Part
Clinical Toxicology Test Systems
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
NDC
Calculator, Drug Dose
2
Product Code
K
21
1160
EndoTool SubQ 2.1
2
Cleared 510(K)
K
20
3434
BlueStar Rx
2
Cleared 510(K)
K
20
2596
Insulia Diabetes Management Companion
2
Cleared 510(K)
K
20
1619
EndoTool IV System
2
Cleared 510(K)
K
20
1337
InPen System
2
Cleared 510(K)
K
20
0443
EndoTool IV 1.10
2
Cleared 510(K)
K
19
0487
InPen Dose Calculator
2
Cleared 510(K)
K
19
2841
InPen System
2
Cleared 510(K)
K
18
1916
d-Nav System
2
Cleared 510(K)
K
18
0366
EndoTool SubQ
2
Cleared 510(K)
Show All 38 Submissions
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Immunological Test Systems
CFR Sub-Part
Microbiology Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Pathology Instrumentation and Accessories
CFR Sub-Part
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
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 26 May 2023 at 11:04 pm
CH
/
diagnostic-devices
/
NDC
/
K211160
View Source
EndoTool SubQ 2.1
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211160
510(k) Type
Traditional
Applicant
Monarch Medical Technologies, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/28/2021
Days to Decision
192 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Biological Stains
Clinical Chemistry Test Systems
Clinical Laboratory Instruments
Clinical Toxicology Test Systems
Diagnostic Devices
NDC
Calculator, Drug Dose
K
21
1160
EndoTool SubQ 2.1
K
20
3434
BlueStar Rx
K
20
2596
Insulia Diabetes Management Companion
K
20
1619
EndoTool IV System
K
20
1337
InPen System
K
20
0443
EndoTool IV 1.10
K
19
0487
InPen Dose Calculator
K
19
2841
InPen System
K
18
1916
d-Nav System
K
18
0366
EndoTool SubQ
Show All 38 Submissions
General Hospital and Personal Use Therapeutic Devices
Immunological Test Systems
Microbiology Devices
Miscellaneous
Pathology Instrumentation and Accessories
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
Toxicology
Medical Genetics
Unknown
CH
/
diagnostic-devices
/
NDC
/
K211160
View Source
EndoTool SubQ 2.1
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211160
510(k) Type
Traditional
Applicant
Monarch Medical Technologies, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/28/2021
Days to Decision
192 days
Submission Type
Summary