Cleared Traditional

K890374 - ABDOMINAL SPATULA

K890374 is an FDA 510(k) clearance for ABDOMINAL SPATULA, manufactured by Kinetic Medical Products. The device is a Class 1 General & Plastic Surgery device with product code GAF cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K890374 · Kinetic Medical Products · General & Plastic Surgery device
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Feb 1989
Decision
11d
Days
Class 1
Risk

K890374 is an FDA 510(k) clearance for the ABDOMINAL SPATULA. Classified as Spatula, Surgical, General & Plastic Surgery (product code GAF), Class I - General Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on February 3, 1989 after a review of 11 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890374

510(k) Number K890374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 03, 1989
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

GAF Device Classification - Class 1, General Controls

Product Code GAF Spatula, Surgical, General & Plastic Surgery
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.