FDA applicant

The Sewing Source, Inc.

Spring Hope, NC9 decisions1993–19960 recalls

FDA records 9 decisions for The Sewing Source, Inc. (Spring Hope, NC) from 1993 to 1996: 9 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and 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 The Sewing Source, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Sewing Source, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Sewing Source, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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The Sewing Source, Inc.

Which product codes does it file in?

What has FDA decided for it lately?