Cleared Traditional

K802485 - SEARLE VASCULAR LOOPS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K802485 · G.D. Searle and Co. · General & Plastic Surgery device
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Feb 1981
Decision
125d
Days
Class 1
Risk

K802485 is an FDA 510(k) clearance for the SEARLE VASCULAR LOOPS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1981 after a review of 125 days - within the typical 510(k) review window.

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 G.D. Searle and Co. devices

Submission Details

510(k) Number K802485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1980
Decision Date February 12, 1981
Days to Decision 125 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
11d slower than avg
Panel avg: 114d · This submission: 125d
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.