Cleared Traditional

K870744 - SURGICAL STARTER KIT (FDA 510(k) Clearance)

K870744 · Devon Industries, Inc. · General & Plastic Surgery device
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Apr 1987
Decision
44d
Days
-
Risk

K870744 is an FDA 510(k) clearance for the SURGICAL STARTER KIT.

Submitted by Devon Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 10, 1987 after a review of 44 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 Devon Industries, Inc. devices

Submission Details

510(k) Number K870744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received February 25, 1987
Decision Date April 10, 1987
Days to Decision 44 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
70d faster than avg
Panel avg: 114d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -