Cleared Traditional

K994436 - SURGI-VISION ESOPHAGEAL STYLET COIL

K994436 is an FDA 510(k) clearance for SURGI-VISION ESOPHAGEAL STYLET COIL, manufactured by Surgi-Vision, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K994436 · Surgi-Vision, Inc. · Radiology device
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Mar 2000
Decision
75d
Days
Class 2
Risk

K994436 is an FDA 510(k) clearance for the SURGI-VISION ESOPHAGEAL STYLET COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Surgi-Vision, Inc. (Columbia, US). The FDA issued a Cleared decision on March 14, 2000 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software 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: 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 Surgi-Vision, Inc. devices

FDA 510(k) Submission Details - K994436

510(k) Number K994436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1999
Decision Date March 14, 2000
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 339
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K994436.
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K994345 · Usa Instruments, Inc. · Feb 2000