Cleared Traditional

SURGICAL PLASTERS (K861695) - FDA 510(k) Clearance

K861695 · Salvaplast Industries · General & Plastic Surgery device
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Aug 1986
Decision
91d
Days
-
Risk

K861695 is an FDA 510(k) clearance for the SURGICAL PLASTERS.

Submitted by Salvaplast Industries (49 348, Israel, IL). The FDA issued a Cleared decision on August 1, 1986 after a review of 91 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.

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Submission Details

510(k) Number K861695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1986
Decision Date August 01, 1986
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -