Cleared Traditional

K800015 - AXIOM VESSEL LOOPS

K800015 is an FDA 510(k) clearance for AXIOM VESSEL LOOPS, manufactured by Axiom Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDC cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K800015 · Axiom Medical, Inc. · General & Plastic Surgery device
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Mar 1980
Decision
81d
Days
Class 1
Risk

K800015 is an FDA 510(k) clearance for the AXIOM VESSEL LOOPS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Axiom Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 81 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 Axiom Medical, Inc. devices

FDA 510(k) Submission Details - K800015

510(k) Number K800015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1980
Decision Date March 25, 1980
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

KDC Device Classification - Class 1, General Controls

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.