510(k) Report

FDA applicant

Gyneco, Inc.

Somerville, NJ5 decisions1984–19860 recalls

FDA records 5 decisions for Gyneco, Inc. (Somerville, NJ) from 1984 to 1986: 5 510(k) clearances. Most are in product codes LDF (Electrode, Pacemaker, Temporary) and HFB (Forceps, Biopsy, Gynecological). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Gyneco, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gyneco, 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?

  • LDFElectrode, Pacemaker, Temporary1decision
  • HFBForceps, Biopsy, Gynecological1decision
  • HHKCurette, Suction, Endometrial (And Accessories)1decision
  • DRMCompressor, Cardiac, External1decision
  • HFEBrush, Endometrial1decision

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.

  • K841275Fine Needle Aspiration DeviceGyneco, Inc. · 19841cites it

What has FDA decided for it lately?

  • K861409Syncare Temporary Cardiac Pacing WireGyneco, Inc. · 1986
  • K853216Master Endomet Biopsy Kit W/Plas Cure 3,4MM-4003,4Gyneco, Inc. · 1986
  • K852357Gyne-Shear Cervical Biopsy Instrument W/Dispis TipGyneco, Inc. · 1985
  • K843941EndocyteGyneco, Inc. · 1985
  • K841275Fine Needle Aspiration DeviceGyneco, Inc. · 1984

All 5 as Gyneco, Inc. →