K233965 is an FDA 510(k) clearance for the UltraDrape UGPIV Barrier and Securement (34-15). This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K233965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |