Cleared Traditional

K955689 - RNS STERILE

K955689 is an FDA 510(k) clearance for RNS STERILE, manufactured by Contour Fabricators of Florida, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K955689 · Contour Fabricators of Florida, Inc. · Cardiovascular device
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May 1996
Decision
153d
Days
Class 1
Risk

K955689 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on May 15, 1996 after a review of 153 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.

View all Contour Fabricators of Florida, Inc. devices

FDA 510(k) Submission Details - K955689

510(k) Number K955689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date May 15, 1996
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 125d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

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 40
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