Cleared Traditional

K910720 - BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER

K910720 is an FDA 510(k) clearance for BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K910720 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 1991
Decision
110d
Days
Class 2
Risk

K910720 is an FDA 510(k) clearance for the BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 110 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K910720

510(k) Number K910720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1991
Decision Date June 10, 1991
Days to Decision 110 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
21d faster than avg
Panel avg: 131d · This submission: 110d
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 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K910720.
PROACT BIOPSY NEEDLE ENCHANCEMENTS
K926559 · Proact, Ltd. · Mar 1993
CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES
K924271 · Core Medical, Inc. · Nov 1992
CORE MEDICAL BIOPSY NEEDLE
K914732 · Core Medical, Inc. · Jan 1992
HYPODERMIC NEEDLES, SINGLE LUMEN
K911397 · Popper & Sons, Inc. · May 1991
HIGH SPEED CORE CUT BIOPSY GUN
K905556 · Uni-Quatro Industries Canada, Inc. · Mar 1991
BAUER FLEXI-TEMNO BIOPSY NEEDLE
K902320 · Proact, Ltd. · Oct 1990
K910720 · BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
Download PDF C.R. Bard, Inc.