510(k) Report

FDA applicant

Medsys, S.A.

Puyallup, WA4 decisions1997–20100 recalls

FDA records 4 decisions for Medsys, S.A. (Puyallup, WA) from 1997 to 2010: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medsys, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Medsys, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery2decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K971229Capnoxygen MaskMedsys, Inc. · 19973cite it
  • K023735Lapman Laparoscope Manipulator System and Accessories, Model 900-001Medsys, S.A. · 20031cites it
  • K062968Lapman Laparoscope Manipulator and Accessories, Model 900-200 SeriesMedsys, S.A. · 20071cites it

What has FDA decided for it lately?

  • K092897Lap LoopMedsys, S.A. · 2010
  • K062968Lapman Laparoscope Manipulator and Accessories, Model 900-200 SeriesMedsys, S.A. · 2007
  • K023735Lapman Laparoscope Manipulator System and Accessories, Model 900-001Medsys, S.A. · 2003
  • K971229Capnoxygen MaskMedsys, Inc. · 1997

All 3 as Medsys, S.A. →The one decision as Medsys, Inc. →