Cleared Traditional

NEOLOOPS (K810890) - FDA 510(k) Clearance

Class I Cardiovascular device.

K810890 · Medical Marketing Systems · Cardiovascular device
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Aug 1981
Decision
151d
Days
Class 1
Risk

K810890 is an FDA 510(k) clearance for the NEOLOOPS. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Medical Marketing Systems (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 151 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K810890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1981
Decision Date August 31, 1981
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
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 - DWS Instruments, Surgical, Cardiovascular

All 14
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K810890.
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
K960143 · GE Medical Systems · Apr 1996
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980
CASTROVIEJO VASCULAR SCISSORS
K792576 · Edward Weck, Inc. · Dec 1979
AORTIC OCCLUDER #000390
K792088 · Edward Weck, Inc. · Oct 1979