Cleared Traditional

K954999 - LILY MULTICANNULA GUIDE

K954999 is an FDA 510(k) clearance for LILY MULTICANNULA GUIDE, manufactured by Lily Imaging Solutions Co.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K954999 · Lily Imaging Solutions Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
155d
Days
Class 2
Risk

K954999 is an FDA 510(k) clearance for the LILY MULTICANNULA GUIDE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Lily Imaging Solutions Co. (Fortuna, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 155 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 Lily Imaging Solutions Co. devices

FDA 510(k) Submission Details - K954999

510(k) Number K954999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date April 04, 1996
Days to Decision 155 days
Submission Type Traditional
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
24d slower than avg
Panel avg: 131d · This submission: 155d
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 308
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K954999.
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
K962077 · C.R. Bard, Inc. · Jul 1996
TEMNO ACHIEVE BIOPSY NEEDLE
K960064 · Bauer Medical, Inc. · Apr 1996
TEMNO DOUBLE SHOT BIOPSY NEEDLE
K960065 · Bauer Medical, Inc. · Apr 1996
18 GAUGE TRU-CUT BIOPSY NEEDLE
K960509 · Baxter Healthcare Corp · Apr 1996
AUTOMATED TRU-CUT BIOPSY DEVICE
K954529 · Baxter Healthcare Corp · Dec 1995
TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE
K954265 · Promex, Inc. · Sep 1995