Cleared Traditional

K021707 - SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS

K021707 is an FDA 510(k) clearance for SINGLE STEP BIOPSY DEVICE, manufactured by Senorx, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K021707 · Senorx, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
83d
Days
Class 2
Risk

K021707 is an FDA 510(k) clearance for the SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, S.... 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 August 14, 2002 after a review of 83 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.

FDA 510(k) Submission Details - K021707

510(k) Number K021707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2002
Decision Date August 14, 2002
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 131d · This submission: 83d
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 365
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K021707.
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K020987 · H.S. Hospital Service S.R.L. · Jun 2002
K021707 · SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
Download PDF FDA Summary Senorx, Inc.