510(k) Report

FDA applicant

Synthasome, Inc.

San Diego, CA3 decisions2009–20140 recalls

FDA records 3 decisions for Synthasome, Inc. (San Diego, CA) from 2009 to 2014: 3 510(k) clearances. All are in product code FTL (Mesh, Surgical, Polymeric). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Synthasome”.

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 Synthasome, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2009: 12014: 2
2009high 2 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Synthasome, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Synthasome, Inc.’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?

  • FTLMesh, Surgical, Polymeric3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K083307Synthasome X-RepairSynthasome, Inc. · 20094cite it

What has FDA decided for it lately?

  • K141394X-RepairSynthasome · 2014
  • K141499X-RepairslSynthasome, Inc. · 2014
  • K083307Synthasome X-RepairSynthasome, Inc. · 2009

All 2 as Synthasome, Inc. →The one decision as Synthasome →