Cleared Traditional

K934370 - BIP BIOPSY NEEDLE MODIFICATION

K934370 is an FDA 510(k) clearance for BIP BIOPSY NEEDLE MODIFICATION, manufactured by Bip USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K934370 · Bip USA, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
181d
Days
Class 2
Risk

K934370 is an FDA 510(k) clearance for the BIP BIOPSY NEEDLE MODIFICATION. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Bip USA, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 181 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 Bip USA, Inc. devices

FDA 510(k) Submission Details - K934370

510(k) Number K934370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date March 07, 1994
Days to Decision 181 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 130d · This submission: 181d
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 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K934370.
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K943304 · Olympus America, Inc. · Dec 1995
RUTNER BIOPSY DEVICE
K950810 · Cook Urological, Inc. · Mar 1995
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
WILSON-COOK GI ASPIRATION NEEDLE
K934356 · Wilson-Cook Medical, Inc. · Jan 1994
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