K040447 is an FDA 510(k) clearance for the TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088. This device is classified as a Lithotriptor, Biliary Mechanical (Class II - Special Controls, product code LQC).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 12, 2004, 21 days after receiving the submission on February 20, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4500.
| 510(k) Number | K040447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2004 |
| Decision Date | March 12, 2004 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LQC — Lithotriptor, Biliary Mechanical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4500 |