FDA applicant
Novare Surgical Systems, Inc.
FDA records 9 decisions for Novare Surgical Systems, Inc. (Pleasant Hill, CA) from 2000 to 2007: 9 510(k) clearances. Most are in product codes DXC (Clamp, Vascular) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 10 predicates, 6 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
How often FDA has decided Novare Surgical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2007
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Novare Surgical Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report