510(k) Report

FDA applicant

Cytocare, Inc.

Aliso Viejo, CA7 decisions1992–19950 recalls

FDA records 7 decisions for Cytocare, Inc. (Aliso Viejo, CA) from 1992 to 1995: 7 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

How often FDA has decided Cytocare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cytocare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cytocare, 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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