CORE ACCESS SURGICAL TECHNOLOGIES, INC.

FDA Device Registration & Listing · Atlanta, GA, US · Registration 3026197439

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3026197439
FEI Number
3026197439
Entity Name
CORE ACCESS SURGICAL TECHNOLOGIES, INC.
City/State/Country
Atlanta, GA, US
Establishment Address
3495 Piedmont Rd NE, Building 11, Suite 905, Atlanta, GA 30305, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
CORE ACCESS SURGICAL TECHNOLOGIES, INC. (Owner Number: 10087237)
Owner / Operator Contact Address
3495 Piedmont Rd NE, Building 11, Suite 905, Atlanta, GA 30305, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212786
PMA Number
N/A

All Registered Proprietary Names

LevaLap

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2023-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CORE ACCESS SURGICAL TECHNOLOGIES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K981334 Richard Wolf Medical Instruments Corp. LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) 1998-09-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026197439. Last updated year: 2026. Please use registration number 3026197439 when referencing this establishment in official correspondence.
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