Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018783201

FEI Number

3018783201

Entity Name

ATHENA SURGICAL

City/State/Country

Minnetonka, MN, US

Establishment Address

6110 Blue Circle Drive, Suite 280, Minnetonka, MN 55343, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Athena Surgical (Owner Number: 10081489)

Owner / Operator Contact Address

6110 Blue Circle Drive, Suite 280, Minnetonka, MN 55343, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210087

PMA Number

N/A

All Registered Proprietary Names

Athena Surgical RMUS System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2021-04-19

Official Correspondent

Greg Slusser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Athena Surgical

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
K222293	Urocure, LLC	ArcSP Suprapubic Sling System	2022-09-21

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3006082230	C.R. BARD, INC.	MADISON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018783201. Last updated year: 2026. Please use registration number 3018783201 when referencing this establishment in official correspondence.