Cleared Special

K051158 - ENCOR 7 GAUGE

K051158 is an FDA 510(k) clearance for ENCOR 7 GAUGE, manufactured by Senorx, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 11-day FDA review.

K051158 · Senorx, Inc. · Gastroenterology & Urology device
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May 2005
Decision
11d
Days
Class 2
Risk

K051158 is an FDA 510(k) clearance for the ENCOR 7 GAUGE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on May 16, 2005 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Senorx, Inc. devices

FDA 510(k) Submission Details - K051158

510(k) Number K051158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2005
Decision Date May 16, 2005
Days to Decision 11 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 131d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 290
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