Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Bristol-Myers SquibbLabelled 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. See the Bristol Myers Squibb group view.
As of Nov 15, 2026, FDA's public records list Surgitek with 29 510(k) clearances. The most recent is a 510(k) clearance dated Mar 6, 1995: QUADRA-COIL URETERAL STENT.
| Mar 6, 1995 | QUADRA-COIL URETERAL STENTK946296 · FAD | 510(k) clearances |
| Feb 7, 1995 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK944391 · FEN | 510(k) clearances |
| Aug 5, 1994 | RIGHT ANGLE UROLOGIC LASER FIBERK943491 · GEX | 510(k) clearances |
| May 24, 1994 | SURGITEK INFUSERK941952 · FAD | 510(k) clearances |
| Jan 11, 1994 | HELICAL STONE/FLATWIRE STONE BASKETSK933260 · FFL | 510(k) clearances |
| Jan 11, 1994 | GRASPING FORCEPSK933261 · FGO | 510(k) clearances |
| Jul 23, 1993 | URETERAL STENTK930733 · FAD | 510(k) clearances |
| Jul 16, 1993 | URETERAL CATHETERK930483 · EYB | 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
