510(k) Report

FDA applicant

American Surgical Sponges

Great Neck, NY1 decision1997–19970 recalls

FDA records 1 decision for American Surgical Sponges (Great Neck, NY) in 1997: 1 510(k) clearance. All are in product code HBA (Neurosurgical Paddie). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for American Surgical Sponges since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Surgical Sponges by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HBANeurosurgical Paddie1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K962807American Surgical Sponges/Neurosurgical SpongesAmerican Surgical Sponges · 19971cites it

What has FDA decided for it lately?

  • K962807American Surgical Sponges/Neurosurgical SpongesAmerican Surgical Sponges · 1997

The one decision as American Surgical Sponges →