EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control— 510(k) K181127

Name: FDA 510(k) clearance K181127
Creator: U.S. Food and Drug Administration
Published: 2019-01-03

Substantially Equivalent

Interscope, Inc.

FDA 510(k) clearance K181127 for EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control, Substantially Equivalent on 2019-01-03. Applicant: Interscope, Inc.. Device class: 2.

Clearance details

Applicant: Interscope, Inc.
Product code: Code PTE
Device class: Class 2
Regulation: 21 CFR 884.1690
Advisory panel: Obstetrics/Gynecology
Date received: 2018-04-30
Decision date: 2019-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whitinsville, MA, US

Download summary PDF View on FDA.gov ↗

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