The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Serirs 2200 Semi-rigid Endoscope.
| Device ID | K924554 |
| 510k Number | K924554 |
| Device Name: | CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE |
| Classification | Angioscope |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Contact | Gregory J Mathison |
| Correspondent | Gregory J Mathison CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-09 |
| Decision Date | 1993-02-25 |