K203226 is an FDA 510(k) clearance for the TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM. This device is classified as a Endoscope, Rigid (Class II - Special Controls, product code GCM).
Submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on May 14, 2021, 193 days after receiving the submission on November 2, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K203226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2020 |
| Decision Date | May 14, 2021 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCM - Endoscope, Rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |