510(k) Report

FDA applicant

Webster Enterprises, Inc.

Webster, NC1 decision1987–19870 recalls

FDA records 1 decision for Webster Enterprises, Inc. (Webster, NC) in 1987: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). 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 Webster Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Webster Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Webster Enterprises, Inc. 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?

  • KKXDrape, Surgical, Antimicrobial1decision

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.

  • K864899Surgical Drape PackWebster Enterprises, Inc. · 19871cites it

What has FDA decided for it lately?

  • K864899Surgical Drape PackWebster Enterprises, Inc. · 1987

The one decision as Webster Enterprises, Inc. →

Other applicant names beginning “Webster”

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

Webster Laboratories, Inc. 5