The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Endoscopic Hook Knife.
| Device ID | K925741 |
| 510k Number | K925741 |
| Device Name: | CLARUS ENDOSCOPIC HOOK KNIFE |
| Classification | Photostimulator, Ac-powered |
| 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 | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-13 |
| Decision Date | 1993-08-24 |