510(k) Report

FDA applicant

Coral Medical, Inc.

Englewood, CO3 decisions1994–19950 recalls

FDA records 3 decisions for Coral Medical, Inc. (Englewood, CO) from 1994 to 1995: 3 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Coral Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Coral Medical, 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?

  • GCJLaparoscope, General & Plastic Surgery2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K944363Model PBD Esu PencilCoral Medical, Inc. · 19941cites it
  • K953123Quik-StitchCoral Medical, Inc. · 19951cites it

What has FDA decided for it lately?

  • K953123Quik-StitchCoral Medical, Inc. · 1995
  • K945170Quik-StitchCoral Medical, Inc. · 1995
  • K944363Model PBD Esu PencilCoral Medical, Inc. · 1994

All 3 as Coral Medical, Inc. →