Cleared Traditional

K830800 - C-LOOPS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K830800 · Concept, Inc. · General & Plastic Surgery device
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Oct 1983
Decision
204d
Days
Class 1
Risk

K830800 is an FDA 510(k) clearance for the C-LOOPS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Concept, Inc. (Walker, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Concept, Inc. devices

Submission Details

510(k) Number K830800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date October 04, 1983
Days to Decision 204 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 slower than avg
Panel avg: 114d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDC Instrument, Surgical, Disposable
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.