Aqueduct 100 Cervical Dilator— 510(k) K160664

Substantially Equivalent

Gtimd, LLC

FDA 510(k) clearance K160664 for Aqueduct 100 Cervical Dilator, Substantially Equivalent on 2016-08-01. Applicant: Gtimd, LLC. Device class: 2.

Clearance details

Applicant: Gtimd, LLC
Product code: Code PON
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Date received: 2016-03-09
Decision date: 2016-08-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Amherst, NH, US

Download summary PDF View on FDA.gov ↗

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K190813 — CrossBay Cervical Dilator Catheter System2019-08-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.