Cleared Traditional

RADOVAN SUBCUTANEOUS TISSUE EXPANDER (K771224) - FDA 510(k) Clearance

K771224 · Heyer Schulte Corp. · General & Plastic Surgery device
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Oct 1977
Decision
98d
Days
-
Risk

K771224 is an FDA 510(k) clearance for the RADOVAN SUBCUTANEOUS TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Heyer Schulte Corp. (Mchenry, US). The FDA issued a Cleared decision on October 11, 1977 after a review of 98 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.

View all Heyer Schulte Corp. devices

Submission Details

510(k) Number K771224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1977
Decision Date October 11, 1977
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -