510(k) Report

FDA applicant

Universal Fiberoptic Repair, Inc.

Pomfret Center, CT1 decision1998–19980 recalls

FDA records 1 decision for Universal Fiberoptic Repair, Inc. (Pomfret Center, CT) in 1998: 1 510(k) clearance. All are in product code FST (Light, Surgical, Fiberoptic). 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 Universal Fiberoptic Repair, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Universal Fiberoptic Repair, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Universal Fiberoptic Repair, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Universal Fiberoptic Repair, 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?

  • FSTLight, Surgical, Fiberoptic1decision

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.

  • K972225Ufr Fiberoptic CableUniversal Fiberoptic Repair, Inc. · 19981cites it

What has FDA decided for it lately?

  • K972225Ufr Fiberoptic CableUniversal Fiberoptic Repair, Inc. · 1998

The one decision as Universal Fiberoptic Repair, Inc. →