The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Series 2100 Endoscope.
| Device ID | K923514 |
| 510k Number | K923514 |
| Device Name: | CLARUS SERIES 2100 ENDOSCOPE |
| Classification | Arthroscope |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Contact | Greory J Mathison |
| Correspondent | Greory J Mathison CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1994-01-07 |