510(k) Report

FDA applicant

C Change Surgical, LLC

Winston-Salem, NC2 decisions2005–20090 recalls

FDA records 2 decisions for C Change Surgical, LLC (Winston-Salem, NC) from 2005 to 2009: 2 510(k) clearances. All are in product code LHC (Warmer, Irrigation Solution). Its devices cite 1 predicate, 0 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, physical medicine panel, where it files most

How often FDA has decided C Change Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — C Change Surgical, LLC 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?

  • LHCWarmer, Irrigation Solution2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K083417Intratemp Solution WarmerC Change Surgical, LLC · 2009
  • K051819C Change Solution WarmerC Change Surgical, LLC · 2005

All 2 as C Change Surgical, LLC →