The following data is part of a premarket notification filed by Lazurite Holdings Llc with the FDA for Arthrofree Wireless Surgical Camera System.
| Device ID | K213860 |
| 510k Number | K213860 |
| Device Name: | ArthroFree Wireless Surgical Camera System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Lazurite Holdings LLC 5000 Euclid Avenue, Suite 206 Cleveland, OH 44103 |
| Contact | Patrick Polito |
| Correspondent | Mike Goodson MCRA, LLC 803 7th Street NW, 3rd Floor Washington, Dc, DC 20001 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-10 |
| Decision Date | 2022-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001744248 | K213860 | 000 |
| 00860001744231 | K213860 | 000 |
| 00860001744224 | K213860 | 000 |
| 00860001744217 | K213860 | 000 |
| 00860001744200 | K213860 | 000 |