Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Gynecare, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Mar 9, 2004: VERSAPOINT RESECTOSCOPIC SYSTEM.
| Mar 9, 2004 | VERSAPOINT RESECTOSCOPIC SYSTEMK040302 · HIH | 510(k) clearances |
| Jan 8, 2002 | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIRK013718 · OTO | 510(k) clearances |
| Jan 18, 2000 | GYNECARE VERSAPOINT G-VAP ELECTRODEK992901 · HIH | 510(k) clearances |
| Mar 1, 1999 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)K982738 · HIH | 510(k) clearances |
| Nov 1, 1996 | SCUBA SYSTEMK962482 · HIH | 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
