Cleared Traditional

SUBCUTANEOUS TISSUE EXPANDER (K790842) - FDA 510(k) Clearance

K790842 · Heyer Schulte Corp. · General & Plastic Surgery device
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Aug 1979
Decision
93d
Days
-
Risk

K790842 is an FDA 510(k) clearance for the 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 August 3, 1979 after a review of 93 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 K790842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1979
Decision Date August 03, 1979
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -