Cleared Traditional

STOP-N-GROW (K960843) - FDA 510(k) Clearance

K960843 · European Touch Co., Inc. · General & Plastic Surgery device
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Aug 1996
Decision
165d
Days
-
Risk

K960843 is an FDA 510(k) clearance for the STOP-N-GROW. Classified as Prosthesis, Nail (product code MQZ).

Submitted by European Touch Co., Inc. (Butler, US). The FDA issued a Cleared decision on August 12, 1996 after a review of 165 days - an extended review cycle.

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 European Touch Co., Inc. devices

Submission Details

510(k) Number K960843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1996
Decision Date August 12, 1996
Days to Decision 165 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
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQZ Prosthesis, Nail
Device Class -