K950712 is an FDA 510(k) clearance for the PORTABLE ENDOSCOPY SYSTEM, a Endoscope, Rigid (Class II — Special Controls, product code GCM), submitted by Laser Optik Systeme GmbH & Co. KG (Mainz, DE). The FDA issued a Cleared decision on May 14, 1996, 455 days after receiving the submission on February 14, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K950712 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 1995 |
| Decision Date | May 14, 1996 |
| Days to Decision | 455 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | GCM — Endoscope, Rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |