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FDA 510(k)

Polygon Resection Device

K-Number: K182675 · 2019-01-04

ApplicantPolygon Medical, Inc.
Decision Date2019-01-04
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Polygon Resection Device is a medical device manufactured by Polygon Medical, Inc.. It received FDA 510(k) clearance on 2019-01-04 under approval number K182675. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polygon Resection Device?

Polygon Resection Device is a medical device that received FDA 510(k) clearance on 2019-01-04. It is manufactured by Polygon Medical, Inc.. The 510(k) number is K182675.

When was Polygon Resection Device approved by the FDA?

Polygon Resection Device received FDA 510(k) clearance on 2019-01-04, under approval number K182675.

What company makes Polygon Resection Device?

Polygon Resection Device is manufactured by Polygon Medical, Inc..

What is the FDA product code for Polygon Resection Device?

The FDA product code for Polygon Resection Device is HIH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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