Cleared Traditional

K854441 - STUART GILMAN'S WEIGHT LOSS PLAN

K854441 · Alpha Therapeutic Corp. · General & Plastic Surgery device
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Feb 1986
Decision
97d
Days
-
Risk

K854441 is an FDA 510(k) clearance for the STUART GILMAN'S WEIGHT LOSS PLAN.

Submitted by Alpha Therapeutic Corp. (Rouses Point, US). The FDA issued a Cleared decision on February 10, 1986 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Alpha Therapeutic Corp. devices

Submission Details

510(k) Number K854441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1985
Decision Date February 10, 1986
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 17
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