FDA applicant

Gynecare, Inc.

Menlo Park, CA4 decisions1996–20002 recalls

FDA records 4 decisions for Gynecare, Inc. (Menlo Park, CA) from 1996 to 2000: 3 510(k) clearances and 1 original PMA approval. Most are in product codes HIH (Hysteroscope (And Accessories)) and MNB (Device, Thermal Ablation, Endometrial). 2 recalls are 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gynecare, Inc. since 2007.

Recalls per year

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Gynecare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 Innovation Center 8 Gynecare, A Div. of Ethicon, Inc. 2 Gynecare Center 1

Gynecare, Inc.

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?

What has been recalled?

Other applicant names beginning “Gynecare”