Cleared Traditional

K890327 - BIOPSY NEEDLE GUIDE ATTACHMENT

K890327 is an FDA 510(k) clearance for BIOPSY NEEDLE GUIDE ATTACHMENT, manufactured by Elscint, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K890327 · Elscint, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
44d
Days
Class 2
Risk

K890327 is an FDA 510(k) clearance for the BIOPSY NEEDLE GUIDE ATTACHMENT. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Elscint, Inc. (Itasca, US). The FDA issued a Cleared decision on March 8, 1989 after a review of 44 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 Elscint, Inc. devices

FDA 510(k) Submission Details - K890327

510(k) Number K890327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date March 08, 1989
Days to Decision 44 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 131d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

Product Code FCG Biopsy Needle
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 - FCG Biopsy Needle

All 92
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K890327.
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · C.R. Bard, Inc. · Jun 1991
MANAN PROSTATIC BIOPSY NEEDLE
K895897 · Manan Medical Products, Inc. · Oct 1989
PRO-CUT BIOPSY NEEDLE
K891777 · Teknar, Inc. · May 1989
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
K882549 · Acuson Corp. · Jul 1988
ROTEX SCREW BIOPSY NEEDLE
K854404 · Meadox Surgimed, Inc. · Dec 1985
MEDSURG ULTRASOUND BIOPSY TRAY
K854289 · Medsurg Industries, Inc. · Nov 1985