The following data is part of a premarket notification filed by Clarus Medical, Llc. with the FDA for Laser Endoscopic Decompression Kit, Model 1100, And Percutaneous Discectomy Kit, Model 1120.
| Device ID | K040424 |
| 510k Number | K040424 |
| Device Name: | LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH Minneapolis, MN 55427 |
| Contact | Tom Barthel |
| Correspondent | Tom Barthel CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH Minneapolis, MN 55427 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-18 |
| Decision Date | 2004-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0671100002SHORT0 | K040424 | 000 |
| B0671100002S0 | K040424 | 000 |