K171348 is an FDA 510(k) clearance for the Pinpoint GT Needle Guide Kits. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 22, 2017, 14 days after receiving the submission on May 8, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K171348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2017 |
| Decision Date | May 22, 2017 |
| Days to Decision | 14 days |
| Submission Type | Special |
| 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 |