510(k) Report

FDA applicant

Chathamborough Research Group, Inc.

Pittsboro, NC4 decisions1986–19921 recall

FDA records 4 decisions for Chathamborough Research Group, Inc. (Pittsboro, NC) from 1986 to 1992: 4 510(k) clearances. Most are in product codes GAW (Suture, Nonabsorbable, Synthetic, Polypropylene) and FMF (Syringe, Piston). 1 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 Chathamborough Research Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chathamborough Research Group, Inc. since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Chathamborough Research Group, 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?

  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene1decision
  • FMFSyringe, Piston1decision
  • GAOSuture, Nonabsorbable1decision
  • FRNPump, Infusion1decision

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.

  • K904906Sharpoint Polypropylene Nonabsorb Surg Sutures UspChathamborough Research Group, Inc. · 19901cites it

What has FDA decided for it lately?

  • K915676Splatter ShieldChathamborough Research Group, Inc. · 1992
  • K904906Sharpoint Polypropylene Nonabsorb Surg Sutures UspChathamborough Research Group, Inc. · 19901 recall
  • K902309Parker Micropump Model 2100Chathamborough Research Group, Inc. · 1990
  • K863034Sharpoint Stainless Steel SutureChathamborough Research Group, Inc. · 1986

All 4 as Chathamborough Research Group, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K904906Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558NMay 20, 2016Class II