Cleared Traditional

K830434 - DISPOSABLE INTRA-ARTICULAR BLADE

K830434 is an FDA 510(k) clearance for DISPOSABLE INTRA-ARTICULAR BLADE, manufactured by Concept, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFA cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K830434 · Concept, Inc. · General & Plastic Surgery device
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Apr 1983
Decision
62d
Days
Class 1
Risk

K830434 is an FDA 510(k) clearance for the DISPOSABLE INTRA-ARTICULAR BLADE. Classified as Blade, Saw, General & Plastic Surgery, Surgical (product code GFA), Class I - General Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 62 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 Concept, Inc. devices

FDA 510(k) Submission Details - K830434

510(k) Number K830434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1983
Decision Date April 12, 1983
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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.

Regulatory Peers - GFA Blade, Saw, General & Plastic Surgery, Surgical

All 11
Devices cleared under the same product code (GFA) and FDA review panel - the closest regulatory comparables to K830434.
FLUID COOLED BONE SAW BLADE, 6000 SERIES
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K896280 · Micro-Aire Surgical Instruments, Inc. · Nov 1989
MICRO-AIRE REPLACEMENT SURG. SAW BLADE
K831714 · Micro-Aire Surgical Instruments, Inc. · Jul 1983
REPLACEMENT SAW BLADES FOR STRYKER AIR
K820601 · Micro-Aire Surgical Instruments, Inc. · Mar 1982
MICRO-AIRE REPLACEMENT SAW BLADES
K811506 · Micro-Aire Surgical Instruments, Inc. · Aug 1981