Cleared Traditional

K960843 - STOP-N-GROW

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

FDA 510(k) Submission Details - K960843

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

MQZ Device Classification - Class 0,

Product Code MQZ Prosthesis, Nail
Device Class -