Cleared Traditional

ALLEN UNIVERSAL STIRRUP (K860177) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K860177 · Edgewater Medical Equipment Systems · General & Plastic Surgery device
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Feb 1986
Decision
25d
Days
Class 1
Risk

K860177 is an FDA 510(k) clearance for the ALLEN UNIVERSAL STIRRUP. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by Edgewater Medical Equipment Systems (Mayfield Hts., US). The FDA issued a Cleared decision on February 11, 1986 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery device framework. 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 Edgewater Medical Equipment Systems devices

Submission Details

510(k) Number K860177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1986
Decision Date February 11, 1986
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.