Cleared Traditional

ACU-HALT (K955661) - FDA 510(k) Clearance

K955661 · Glederer & Co., Inc. · General & Plastic Surgery device
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Dec 1996
Decision
384d
Days
-
Risk

K955661 is an FDA 510(k) clearance for the ACU-HALT.

Submitted by Glederer & Co., Inc. (Paterson, US). The FDA issued a Cleared decision on December 30, 1996 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K955661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1995
Decision Date December 30, 1996
Days to Decision 384 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 115d · This submission: 384d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -