The following data is part of a premarket notification filed by Core Access Surgical Technologies, Inc. with the FDA for Levalap Laparoscopic Access Device.
| Device ID | K212786 |
| 510k Number | K212786 |
| Device Name: | LevaLap Laparoscopic Access Device |
| Classification | Insufflator, Laparoscopic |
| Applicant | Core Access Surgical Technologies, Inc. 3495 Piedmont Road, NE Building 11, Suite 905 Atlanta, GA 30305 |
| Contact | Marianne D. Jacklyn |
| Correspondent | Marianne D. Jacklyn Core Access Surgical Technologies, Inc. 3495 Piedmont Road, NE Building 11, Suite 905 Atlanta, GA 30305 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-01 |
| Decision Date | 2022-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006094201 | K212786 | 000 |