510(k) Report

FDA applicant

Pinnacle Biologics, Inc.

Bannockburn2 decisions1995–20000 recalls

FDA records 2 decisions for Pinnacle Biologics, Inc. (Bannockburn) from 1995 to 2000: 2 original PMA approvals. Most are in product codes MVF (System, Laser, Photodynamic Therapy) and MVG (System, Laser, Fiber Optic, Photodynamic Therapy). 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 Pinnacle Biologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pinnacle Biologics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Pinnacle”

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