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Subpart B—Diagnostic Devices
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Subpart B—Obstetrical and Gynecological Diagnostic Devices
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HIR
Perineometer
2
Product Code
OCQ
Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence
2
Product Code
PTE
Endoscopic Morcellator Gastroenterology
2
Product Code
K
18
1127
EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
2
Cleared 510(K)
K
17
0120
EndoRotor
2
Cleared 510(K)
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Last synced on 11 July 2025 at 11:06 pm
GU
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
PTE
/
K170120
View Source
EndoRotor
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170120
510(k) Type
Traditional
Applicant
Interscope, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/18/2017
Days to Decision
95 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
HIR
Perineometer
OCQ
Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence
PTE
Endoscopic Morcellator Gastroenterology
K
18
1127
EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
K
17
0120
EndoRotor
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
PTE
/
K170120
View Source
EndoRotor
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170120
510(k) Type
Traditional
Applicant
Interscope, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/18/2017
Days to Decision
95 days
Submission Type
Summary