Cleared Traditional

K963794 - PUNCTURENEEDLE

K963794 is the FDA 510(k) clearance for PUNCTURENEEDLE by Ferguson Medical. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 545-day FDA review.

K963794 · Ferguson Medical · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
545d
Days
Class 2
Risk

K963794 is an FDA 510(k) clearance for the PUNCTURENEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on March 19, 1998 after a review of 545 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Ferguson Medical devices

Submission Details

510(k) Number K963794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1996
Decision Date March 19, 1998
Days to Decision 545 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
415d slower than avg
Panel avg: 130d · This submission: 545d
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 172
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K963794.
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · Medical Device Technologies, Inc. · May 1999
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
K982960 · Medical Device Technologies, Inc. · Sep 1998
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT
K982085 · Medical Device Technologies, Inc. · Jul 1998
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
K980226 · Medical Device Technologies, Inc. · Feb 1998
MANAN LIVER BIOPSY KIT
K980452 · Medical Device Technologies, Inc. · Feb 1998
MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
K980211 · Manan Medical Products, Inc. · Feb 1998