GelPOINT Path Transanal Access Platform
K-Number: K171701 · 2017-07-20
ApplicantApplied Medical Resources Corp.
Decision Date2017-07-20
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
GelPOINT Path Transanal Access Platform is a medical device manufactured by Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2017-07-20 under approval number K171701. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GelPOINT Path Transanal Access Platform?
GelPOINT Path Transanal Access Platform is a medical device that received FDA 510(k) clearance on 2017-07-20. It is manufactured by Applied Medical Resources Corp.. The 510(k) number is K171701.
When was GelPOINT Path Transanal Access Platform approved by the FDA?
GelPOINT Path Transanal Access Platform received FDA 510(k) clearance on 2017-07-20, under approval number K171701.
What company makes GelPOINT Path Transanal Access Platform?
GelPOINT Path Transanal Access Platform is manufactured by Applied Medical Resources Corp..
What is the FDA product code for GelPOINT Path Transanal Access Platform?
The FDA product code for GelPOINT Path Transanal Access Platform is FER.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.