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FDA 510(k)

UltraDrape UGPIV Barrier and Securement (34-15)

K-Number: K233965 · 2024-08-15

ApplicantParker Laboratories, Inc.
Decision Date2024-08-15
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UltraDrape UGPIV Barrier and Securement (34-15) is a medical device manufactured by Parker Laboratories, Inc.. It received FDA 510(k) clearance on 2024-08-15 under approval number K233965. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraDrape UGPIV Barrier and Securement (34-15)?

UltraDrape UGPIV Barrier and Securement (34-15) is a medical device that received FDA 510(k) clearance on 2024-08-15. It is manufactured by Parker Laboratories, Inc.. The 510(k) number is K233965.

When was UltraDrape UGPIV Barrier and Securement (34-15) approved by the FDA?

UltraDrape UGPIV Barrier and Securement (34-15) received FDA 510(k) clearance on 2024-08-15, under approval number K233965.

What company makes UltraDrape UGPIV Barrier and Securement (34-15)?

UltraDrape UGPIV Barrier and Securement (34-15) is manufactured by Parker Laboratories, Inc..

What is the FDA product code for UltraDrape UGPIV Barrier and Securement (34-15)?

The FDA product code for UltraDrape UGPIV Barrier and Securement (34-15) is ITX.

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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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