510(k) Report

FDA applicant

Aperta, LLC

Casey Key Nokomis, FL1 decision2009–20092 recalls

FDA records 1 decision for Aperta, LLC (Casey Key Nokomis, FL) in 2009: 1 510(k) clearance. All are in product code FTL (Mesh, Surgical, Polymeric). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are 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 Aperta, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2011

2011: 2
2009high 2 (2011) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Aperta, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aperta, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FTLMesh, Surgical, Polymeric1decision

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?

  • K093166Wittmann PatchAperta, LLC · 20092 recalls

The one decision as Aperta, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K093166The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only.…Jun 22, 2011
  • K093166The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound…Jun 22, 2011