K062475 is an FDA 510(k) clearance for the LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by The Laryngeal Mask Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on May 9, 2007, 258 days after receiving the submission on August 24, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K062475 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2006 |
| Decision Date | May 09, 2007 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFK — Lithotriptor, Electro-hydraulic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4480 |