FDA applicant
Urogyn, Ltd.
FDA records 2 decisions for Urogyn, Ltd. (Natick, MA) from 2000 to 2002: 2 510(k) clearances. All are in product code KNA (Instrument, Manual, Specialized…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Urogyn, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Urogyn, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Urogyn, Ltd.’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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