GelPOINT Transvaginal Access Platform— 510(k) K143308

Name: FDA 510(k) clearance K143308
Creator: U.S. Food and Drug Administration
Published: 2015-10-13

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K143308 for GelPOINT Transvaginal Access Platform, Substantially Equivalent on 2015-10-13. Applicant: Applied Medical Resources. Device class: 2.

Clearance details

Applicant: Applied Medical Resources
Product code: Code HEW
Device class: Class 2
Regulation: 21 CFR 884.1640
Advisory panel: Obstetrics/Gynecology
Date received: 2014-11-18
Decision date: 2015-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

Download summary PDF View on FDA.gov ↗

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