UltraDrape UGPIV Barrier and Securement (34-15)— 510(k) K233965

Name: FDA 510(k) clearance K233965
Creator: U.S. Food and Drug Administration
Published: 2024-08-15

Substantially Equivalent

Parker Laboratories, Inc.

FDA 510(k) clearance K233965 for UltraDrape UGPIV Barrier and Securement (34-15), Substantially Equivalent on 2024-08-15. Applicant: Parker Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Parker Laboratories, Inc.
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2023-12-15
Decision date: 2024-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITX

view all

K261170 — BA-004CC2026-08-12
K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
K260161 — SmartGuide Disposable Guides and Grids2026-07-30
K262474 — ND Needle Guidance System2026-07-27
K261014 — Accuro® 3S Needle Guide Kit2026-07-24

More clearances from Parker Laboratories, Inc.

view all

K953673 — ECLIPSE PROBE COVER1996-03-14
K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS1995-02-23
K864556 — AQUALUBE(TM)1986-12-01
K861239 — ACRYLIC SOLDER1986-04-17
K855167 — DYNA SYSTEM1986-03-04

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.