Cleared Traditional

JAIN GRAFT ASSIST (K904536) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K904536 · Jain Surgical Equipment, Inc. · General & Plastic Surgery device
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Nov 1990
Decision
56d
Days
Class 1
Risk

K904536 is an FDA 510(k) clearance for the JAIN GRAFT ASSIST. Classified as Retainer, Surgical (product code GCZ), Class I - General Controls.

Submitted by Jain Surgical Equipment, Inc. (Kalamazoo, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Jain Surgical Equipment, Inc. devices

Submission Details

510(k) Number K904536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1990
Decision Date November 29, 1990
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GCZ Retainer, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.