Cleared Traditional

K001328 - INTRODUCER SHEATH

K001328 is an FDA 510(k) clearance for INTRODUCER SHEATH, manufactured by Novasys Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEC cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K001328 · Novasys Medical, Inc. · Gastroenterology & Urology device
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Jul 2000
Decision
82d
Days
Class 2
Risk

K001328 is an FDA 510(k) clearance for the INTRODUCER SHEATH. Classified as Obturator, For Endoscope (product code FEC), Class II - Special Controls.

Submitted by Novasys Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 17, 2000 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Novasys Medical, Inc. devices

FDA 510(k) Submission Details - K001328

510(k) Number K001328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2000
Decision Date July 17, 2000
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEC Device Classification - Class 2, Special Controls

Product Code FEC Obturator, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.