K190576 is an FDA 510(k) clearance for the WalterLorenz Surgical Assist Arm Scope Holder. This device is classified as a Endoscope Holder (Class II - Special Controls, product code OCV).
Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on June 5, 2019, 91 days after receiving the submission on March 6, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Hold Endoscope In A Desired Position During Procedures..
| 510(k) Number | K190576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2019 |
| Decision Date | June 05, 2019 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OCV — Endoscope Holder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Hold Endoscope In A Desired Position During Procedures. |