Cleared Traditional

K845036 - TISSUE EXPANDERS FOR RECONSTRUC-SURGERY...

K845036 · Progress Mankind Technology · General & Plastic Surgery device
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Jun 1985
Decision
181d
Days
-
Risk

K845036 is an FDA 510(k) clearance for the TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Progress Mankind Technology (Hopkins, US). The FDA issued a Cleared decision on June 26, 1985 after a review of 181 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 K845036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date June 26, 1985
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -