FDA 510(k)

ORISE Gel

K-Number: K180068 · 2018-09-28

Decision Date2018-09-28

Product CodePLL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ORISE Gel is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2018-09-28 under approval number K180068. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORISE Gel?

ORISE Gel is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Boston Scientific. The 510(k) number is K180068.

When was ORISE Gel approved by the FDA?

ORISE Gel received FDA 510(k) clearance on 2018-09-28, under approval number K180068.

What company makes ORISE Gel?

ORISE Gel is manufactured by Boston Scientific.

What is the FDA product code for ORISE Gel?

The FDA product code for ORISE Gel is PLL.

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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.