Cleared Traditional

K063697 - SPECIAL SPROTTE

K063697 is the FDA 510(k) clearance for SPECIAL SPROTTE by PAJUNK GmbH Medizintechnologie. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K063697 · PAJUNK GmbH Medizintechnologie · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
63d
Days
Class 2
Risk

K063697 is an FDA 510(k) clearance for the SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on February 14, 2007 after a review of 63 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 Medizintechnologie devices

Submission Details

510(k) Number K063697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date February 14, 2007
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
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 161
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K063697.
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US
K093068 · C.R. Bard, Inc. · Nov 2009
VACORA VACUUM ASSISTED BIOPSY SYSTEM
K082681 · C.R. Bard, Inc. · Oct 2008
DELTACUT (APPARATUS AND CANNULA)
K063233 · PAJUNK GmbH Medizintechnologie · Apr 2007
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
K062832 · C.R. Bard, Inc. · Oct 2006
MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
K052802 · Manan Medical Products, Inc. · Nov 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · Boston Scientific Corp · Jun 2005