FDA applicant

Mist, Inc.

Great Neck, NY8 decisions1995–19970 recalls

FDA records 8 decisions for Mist, Inc. (Great Neck, NY) from 1995 to 1997: 8 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and JOS (Electrode, Electrosurgical). Its devices cite 2 predicates, 0 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, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Mist, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mist, 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

Mist, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?