K924134 is an FDA 510(k) clearance for the LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS. This device is classified as a Endoscope, Battery-powered And Accessories (Class II - Special Controls, product code GCS).
Submitted by Leisegang Medical, Inc. (Boca Raton, US). The FDA issued a Cleared decision on July 2, 1993, 318 days after receiving the submission on August 18, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K924134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1992 |
| Decision Date | July 02, 1993 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | GCS — Endoscope, Battery-powered And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |