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FDA 510(k)

Steriking® LT-Blueline Pouches with Tyvek®

K-Number: K231996 · 2023-09-07

ApplicantWipak OY
Decision Date2023-09-07
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steriking® LT-Blueline Pouches with Tyvek® is a medical device manufactured by Wipak OY. It received FDA 510(k) clearance on 2023-09-07 under approval number K231996. 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® LT-Blueline Pouches with Tyvek®?

Steriking® LT-Blueline Pouches with Tyvek® is a medical device that received FDA 510(k) clearance on 2023-09-07. It is manufactured by Wipak OY. The 510(k) number is K231996.

When was Steriking® LT-Blueline Pouches with Tyvek® approved by the FDA?

Steriking® LT-Blueline Pouches with Tyvek® received FDA 510(k) clearance on 2023-09-07, under approval number K231996.

What company makes Steriking® LT-Blueline Pouches with Tyvek®?

Steriking® LT-Blueline Pouches with Tyvek® is manufactured by Wipak OY.

What is the FDA product code for Steriking® LT-Blueline Pouches with Tyvek®?

The FDA product code for Steriking® LT-Blueline Pouches with Tyvek® is FRG.

Other Devices by Wipak OY

K221377SteriKing LT-Blueline Pouches with Tyvek K221016Steriking Packaging for Medical Devices K210810Steiking Packaging for Medical Devices K231999Steriking® LT-Blueline Pouches with Tyvek® K221379Steriking LT-Blueline Pouches with Tyvek K232625Steriking® Pouch for Robotic Instruments

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Related Devices (Code: FRG)

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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.

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