Cleared Traditional

MEDICAL PROCEDURE TRAY, MODIFICATION (K930884) - FDA 510(k) Clearance

K930884 · Enpak Medical Corp. · General & Plastic Surgery device
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Mar 1995
Decision
762d
Days
-
Risk

K930884 is an FDA 510(k) clearance for the MEDICAL PROCEDURE TRAY, MODIFICATION.

Submitted by Enpak Medical Corp. (Salt Lake City, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 762 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Enpak Medical Corp. devices

Submission Details

510(k) Number K930884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1993
Decision Date March 21, 1995
Days to Decision 762 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
647d slower than avg
Panel avg: 115d · This submission: 762d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -