Cleared Traditional

K810045 - I.M. RETROGRADE BLADES

K810045 is an FDA 510(k) clearance for I.M. RETROGRADE BLADES, manufactured by Hogan & Hartson. The device is a Class 1 General & Plastic Surgery device with product code GFA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K810045 · Hogan & Hartson · General & Plastic Surgery device
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Feb 1981
Decision
35d
Days
Class 1
Risk

K810045 is an FDA 510(k) clearance for the I.M. RETROGRADE BLADES. Classified as Blade, Saw, General & Plastic Surgery, Surgical (product code GFA), Class I - General Controls.

Submitted by Hogan & Hartson (Mchenry, US). The FDA issued a Cleared decision on February 12, 1981 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Hogan & Hartson devices

FDA 510(k) Submission Details - K810045

510(k) Number K810045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1981
Decision Date February 12, 1981
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

GFA Device Classification - Class 1, General Controls

Product Code GFA Blade, Saw, General & Plastic Surgery, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.