Cleared Traditional

CHIBA SONO (K113209) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113209 · Pajunk GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
21d
Days
Class 2
Risk

K113209 is an FDA 510(k) clearance for the CHIBA SONO. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Pajunk GmbH (Geisingen, DE). The FDA issued a Cleared decision on November 21, 2011 after a review of 21 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 Pajunk GmbH devices

Submission Details

510(k) Number K113209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date November 21, 2011
Days to Decision 21 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
109d faster than avg
Panel avg: 130d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 100
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K113209.
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
K170008 · Cook Incorporated · Feb 2017
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc. · Mar 2016
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
K111100 · C.R. Bard, Inc. · Jun 2011
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
K103359 · C.R. Bard, Inc. · Dec 2010
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US
K093068 · C.R. Bard, Inc. · Nov 2009