Cleared Traditional

K801175 - SILASTIC II MAMMARY IMPLANT (FDA 510(k) Clearance)

K801175 · Dow Corning Corp. Healthcare Industries Materials · General & Plastic Surgery device
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Dec 1980
Decision
216d
Days
-
Risk

K801175 is an FDA 510(k) clearance for the SILASTIC II MAMMARY IMPLANT.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 216 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.

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Submission Details

510(k) Number K801175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1980
Decision Date December 18, 1980
Days to Decision 216 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
102d slower than avg
Panel avg: 114d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -