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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 the device name listed in this FDA 510(k) record. The listed applicant is Parker Laboratories, Inc.. It received FDA 510(k) clearance on 2024-08-15 under 510(k) 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. The listed applicant is Parker Laboratories, Inc.. The 510(k) number is K233965.

When did UltraDrape UGPIV Barrier and Securement (34-15) receive FDA 510(k) clearance?

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

Who is the listed applicant for UltraDrape UGPIV Barrier and Securement (34-15)?

The FDA 510(k) record lists Parker Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

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.

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