Cleared Traditional

MAJOR DRESSING TRAY (K811090) - FDA 510(k) Clearance

K811090 · Cunningham Woodland, Inc. · General & Plastic Surgery device
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May 1981
Decision
17d
Days
-
Risk

K811090 is an FDA 510(k) clearance for the MAJOR DRESSING TRAY.

Submitted by Cunningham Woodland, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981 after a review of 17 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 Cunningham Woodland, Inc. devices

Submission Details

510(k) Number K811090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date May 08, 1981
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -