510(k) Report

FDA applicant

Stephen Chakoff, Inc.

Miami, FL16 decisions1993–19950 recalls

FDA records 16 decisions for Stephen Chakoff, Inc. (Miami, FL) from 1993 to 1995: 16 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FDG (Retractor, Fiberoptic). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Stephen Chakoff, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stephen Chakoff, 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 “Stephen”

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