Cleared Traditional

K102771 - BIOPSY HANDY, MRI BIOPSY HANDY

K102771 is an FDA 510(k) clearance for BIOPSY HANDY, manufactured by Somatex Medical Technologies GmbH. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K102771 · Somatex Medical Technologies GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
273d
Days
Class 2
Risk

K102771 is an FDA 510(k) clearance for the BIOPSY HANDY, MRI BIOPSY HANDY. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Somatex Medical Technologies GmbH (Cambridge, US). The FDA issued a Cleared decision on June 24, 2011 after a review of 273 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Somatex Medical Technologies GmbH devices

FDA 510(k) Submission Details - K102771

510(k) Number K102771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date June 24, 2011
Days to Decision 273 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
142d slower than avg
Panel avg: 131d · This submission: 273d
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 328
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K102771.
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K092338 · Medax Unipersonale Srl · May 2011