Cleared Traditional

ELPER(TM) BARRIER INTEGRITY MONITORING (K931153) - FDA 510(k) Clearance

K931153 · Igea, S.R.L. · General & Plastic Surgery device
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Nov 1993
Decision
254d
Days
-
Risk

K931153 is an FDA 510(k) clearance for the ELPER(TM) BARRIER INTEGRITY MONITORING.

Submitted by Igea, S.R.L. (Washington, US). The FDA issued a Cleared decision on November 18, 1993 after a review of 254 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 Igea, S.R.L. devices

Submission Details

510(k) Number K931153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date November 18, 1993
Days to Decision 254 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 115d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -