Cleared Traditional

K934371 - BIP MULTI MODIFICATION

K934371 is an FDA 510(k) clearance for BIP MULTI MODIFICATION, manufactured by Bip USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K934371 · Bip USA, Inc. · Gastroenterology & Urology device
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Apr 1994
Decision
233d
Days
Class 2
Risk

K934371 is an FDA 510(k) clearance for the BIP MULTI MODIFICATION. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Bip USA, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 233 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 - K934371

510(k) Number K934371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date April 28, 1994
Days to Decision 233 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
103d slower than avg
Panel avg: 130d · This submission: 233d
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 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K934371.
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MANAN ADAPTER FOR BARD BIOPTY SYSTEM
K940365 · Manan Medical Products, Inc. · Feb 1994
MANAN ADAPTER FOR BIP BIOPSY DEVICE
K933448 · Manan Medical Products, Inc. · Nov 1993