510(k) Report

FDA applicant

Suretek Medical

Greenville, SC4 decisions2006–20060 recalls

FDA records 4 decisions for Suretek Medical (Greenville, SC) in 2006: 4 510(k) clearances. Most are in product codes NUJ (Electrosurgical, Cutting & Coagulation…) and JOW (Sleeve, Limb, Compressible). Its devices cite 27 predicates, 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, general and plastic surgery panel, where it files most

How often FDA has decided Suretek Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Suretek Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Suretek Medical 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?

  • NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed3decisions
  • JOWSleeve, Limb, Compressible1decision

Whose devices does it build on?

Its devices cite 27 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006
  • K052690Suretek Reprocessed Laparoscopic InstrumentsSuretek Medical · 2006
  • K052695Suretek Medical Reprocessed Arthroscopic Blades and BursSuretek Medical · 2006
  • K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006

All 4 as Suretek Medical →