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FDA 510(k)

Steriking® Pouch for Robotic Instruments

K-Number: K232625 · 2024-06-07

ApplicantWipak OY
Decision Date2024-06-07
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steriking® Pouch for Robotic Instruments is a medical device manufactured by Wipak OY. It received FDA 510(k) clearance on 2024-06-07 under approval number K232625. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steriking® Pouch for Robotic Instruments?

Steriking® Pouch for Robotic Instruments is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by Wipak OY. The 510(k) number is K232625.

When was Steriking® Pouch for Robotic Instruments approved by the FDA?

Steriking® Pouch for Robotic Instruments received FDA 510(k) clearance on 2024-06-07, under approval number K232625.

What company makes Steriking® Pouch for Robotic Instruments?

Steriking® Pouch for Robotic Instruments is manufactured by Wipak OY.

What is the FDA product code for Steriking® Pouch for Robotic Instruments?

The FDA product code for Steriking® Pouch for Robotic Instruments is FRG.

Other Devices by Wipak OY

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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.