Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Gyneco, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated May 5, 1986: SYNCARE TEMPORARY CARDIAC PACING WIRE.
| May 5, 1986 | SYNCARE TEMPORARY CARDIAC PACING WIREK861409 · LDF | 510(k) clearances |
| Apr 2, 1986 | MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4K853216 · HHK | 510(k) clearances |
| Jul 5, 1985 | GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIPK852357 · HFB | 510(k) clearances |
| Feb 25, 1985 | ENDOCYTEK843941 · HFE | 510(k) clearances |
| Aug 17, 1984 | FINE NEEDLE ASPIRATION DEVICEK841275 · DRM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
