FDA 510(k)

Universal Seal (5-12 mm)

K-Number: K231358 · 2023-07-05

Decision Date2023-07-05

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Universal Seal (5-12 mm) is a medical device manufactured by Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2023-07-05 under approval number K231358. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Universal Seal (5-12 mm)?

Universal Seal (5-12 mm) is a medical device that received FDA 510(k) clearance on 2023-07-05. It is manufactured by Intuitive Surgical, Inc.. The 510(k) number is K231358.

When was Universal Seal (5-12 mm) approved by the FDA?

Universal Seal (5-12 mm) received FDA 510(k) clearance on 2023-07-05, under approval number K231358.

What company makes Universal Seal (5-12 mm)?

Universal Seal (5-12 mm) is manufactured by Intuitive Surgical, Inc..

What is the FDA product code for Universal Seal (5-12 mm)?

The FDA product code for Universal Seal (5-12 mm) is GCJ.

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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.