EndoRotor— 510(k) K170120

Substantially Equivalent

Interscope, Inc.

FDA 510(k) clearance K170120 for EndoRotor, Substantially Equivalent on 2017-04-18. 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: 2017-01-13
Decision date: 2017-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worchester, MA, US

Download summary PDF View on FDA.gov ↗

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