510(k) Report

FDA applicant

Quill Medical, Inc.

Research Triangle Park, NC4 decisions2004–20050 recalls

FDA records 4 decisions for Quill Medical, Inc. (Research Triangle Park, NC) from 2004 to 2005: 4 510(k) clearances. Most are in product codes NEW (Suture, Surgical, Absorbable, Polydioxanone) and GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). Its devices cite 9 predicates, 3 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 Quill Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quill Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • NEWSuture, Surgical, Absorbable, Polydioxanone2decisions
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene1decision
  • GARSuture, Nonabsorbable, Synthetic, Polyamide1decision

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 3 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.

  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 200511cite it
  • K052373Quill Nonabsorbable Polypropylene Barbed SutureQuill Medical, Inc. · 20056cite it
  • K042075Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 20044cite it

What has FDA decided for it lately?

  • K052900Quill Nonabsorbable Nylon Barbed SutureQuill Medical, Inc. · 2005
  • K052373Quill Nonabsorbable Polypropylene Barbed SutureQuill Medical, Inc. · 2005
  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  • K042075Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2004

All 4 as Quill Medical, Inc. →