FDA applicant

Gynecare Innovation Center

Sunnyvale, CA8 decisions1996–19980 recalls

FDA records 8 decisions for Gynecare Innovation Center (Sunnyvale, CA) from 1996 to 1998: 8 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and FJL (Resectoscope). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Gynecare Innovation Center’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gynecare Innovation Center since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Gynecare”

FDA records each applicant name separately; these may or may not be the same firm.

Gynecare, Inc. 4 Gynecare, A Div. of Ethicon, Inc. 2 Gynecare Center 1

Gynecare Innovation Center

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Gynecare”