K905552 is an FDA 510(k) clearance for the LAPAROLITH. This device is classified as a Lithotriptor, Biliary Mechanical (Class II - Special Controls, product code LQC).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on December 17, 1991, 371 days after receiving the submission on December 11, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4500.
| 510(k) Number | K905552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 1990 |
| Decision Date | December 17, 1991 |
| Days to Decision | 371 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LQC — Lithotriptor, Biliary Mechanical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4500 |