510(k) Report

FDA applicant

Silipos, Inc.

New York, NY4 decisions1994–19960 recalls

FDA records 4 decisions for Silipos, Inc. (New York, NY) from 1994 to 1996: 4 510(k) clearances. Most are in product codes MDA (Elastomer, Silicone, For Scar Management) and FQL (Stocking, Medical Support (For General Medical…). 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 Silipos, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Silipos, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Silipos, 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?

  • MDAElastomer, Silicone, For Scar Management3decisions
  • FQLStocking, Medical Support (For General Medical Purposes)1decision

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.

  • K942695Tri Block Polumer Gel SheetingSilipos, Inc. · 19941cites it

What has FDA decided for it lately?

  • K955664Sterilized Tri Block Polymer Gel SheetSilipos, Inc. · 1996
  • K944240Soft SockSilipos, Inc. · 1994
  • K942695Tri Block Polumer Gel SheetingSilipos, Inc. · 1994
  • K932048Silicone Gel SheetingSilipos, Inc. · 1994

All 4 as Silipos, Inc. →