The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Models 1230 And 1231 Laparo-needle.
| Device ID | K915725 |
| 510k Number | K915725 |
| Device Name: | CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE |
| Classification | Pneumoperitoneum Needle |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Contact | Gregory Mathison |
| Correspondent | Gregory Mathison CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-20 |
| Decision Date | 1992-11-16 |