Cleared Traditional

UltraDrape UGPIV Barrier and Securement (34-15)

K233965 · Parker Laboratories, Inc. · Radiology
Aug 2024
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K233965 is an FDA 510(k) clearance for the UltraDrape UGPIV Barrier and Securement (34-15), a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Parker Laboratories, Inc. (Fairfield, US). The FDA issued a Cleared decision on August 15, 2024, 244 days after receiving the submission on December 15, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K233965 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2023
Decision Date August 15, 2024
Days to Decision 244 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code ITX — Transducer, Ultrasonic, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

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