Cleared Traditional

K874551 - ENVINET(TM) (FDA 510(k) Clearance)

K874551 · Marion Laboratories, Inc. · General & Plastic Surgery device
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Jan 1988
Decision
79d
Days
-
Risk

K874551 is an FDA 510(k) clearance for the ENVINET(TM). Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marion Laboratories, Inc. devices

Submission Details

510(k) Number K874551 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 04, 1987
Decision Date January 22, 1988
Days to Decision 79 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
35d faster than avg
Panel avg: 114d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -