The following data is part of a premarket notification filed by Ark Surgical, Ltd. with the FDA for Lapbox Tissue Containment Removal System.
| Device ID | K221365 |
| 510k Number | K221365 |
| Device Name: | LapBox Tissue Containment Removal System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ARK Surgical, Ltd. 13 Wadi El Hadj Nazareth, IL |
| Contact | Stav Tori |
| Correspondent | Bosmat Friedman ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-12 |
| Decision Date | 2022-08-25 |