Cleared Traditional

K022286 - ENCIRCLE LOCALIZATION DEVICE

K022286 is an FDA 510(k) clearance for ENCIRCLE LOCALIZATION DEVICE, manufactured by Vivant Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K022286 · Vivant Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
88d
Days
Class 2
Risk

K022286 is an FDA 510(k) clearance for the ENCIRCLE LOCALIZATION DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Vivant Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 11, 2002 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Vivant Medical, Inc. devices

FDA 510(k) Submission Details - K022286

510(k) Number K022286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2002
Decision Date October 11, 2002
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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.

Regulatory Peers - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K022286.
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
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SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
K021707 · Senorx, Inc. · Aug 2002
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K012023 · Senorx, Inc. · Sep 2001
MAMMOTOME HAND HELD PROBE, MODEL MHH8
K003297 · Ethicon Endo-Surgery, Inc. · Jan 2001