510(k) Report

FDA applicant

Athena Surgical, LLC

Minnetonka, MN1 decision2021–20210 recalls

FDA records 1 decision for Athena Surgical, LLC (Minnetonka, MN) in 2021: 1 510(k) clearance. All are in product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Athena Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Athena Surgical, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K210087Athena Surgical RMUS SystemAthena Surgical, LLC · 2021

The one decision as Athena Surgical, LLC →

Other applicant names beginning “Athena”

FDA records each applicant name separately; these may or may not be the same firm.

Athena Gtx 8Athena Technology, Inc. 3Athena Feminine Technologies, Inc. 2Athena Medical Corp. 2Athena Mfg., Inc. 1