Data / Medical devices / United States / Core Access Surgical Technologies, Inc.
Core Access Surgical Technologies, Inc.: FDA-registered device maker in Atlanta, GA, United States, 1 510(k) clearance
Core Access Surgical Technologies, Inc. is registered with the FDA (registration 3026197439) in Atlanta, GA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026197439
- Address
- 3495 Piedmont Rd NE Building 11, Suite 905, Atlanta, GA, United States, 30305
- Owner or operator
- CORE ACCESS SURGICAL TECHNOLOGIES, INC. (10087237)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 31, 2023
- Registered through
- 2026
- Brand names listed
- LevaLap
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2022 | K212786 | LevaLap Laparoscopic Access Device | HIF | Substantially Equivalent | Core Access Surgical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.