Cleared Traditional

K910190 - BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

K910190 is an FDA 510(k) clearance for BARD MONOPTY DISPOSABLE CORE BIOPSY INS..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K910190 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
212d
Days
Class 2
Risk

K910190 is an FDA 510(k) clearance for the BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 212 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.

FDA 510(k) Submission Details - K910190

510(k) Number K910190 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 16, 1991
Decision Date August 16, 1991
Days to Decision 212 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
81d slower than avg
Panel avg: 131d · This submission: 212d
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 365
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K910190.
MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE
K914874 · Manan Medical Products, Inc. · Feb 1992
AUTO-VAC BIOPSY NEEDLE
K912892 · Angiomed GmbH & Co. Medizintechnik KG · Feb 1992
APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501
K913098 · Dlp, Inc. · Nov 1991
MEADOX(R) SURGIMED(R) BIOPSY GUN II
K911635 · Meadox Surgimed, Inc. · Jun 1991
CCC CROWN-CORE-CUT-NEEDLE
K905557 · Uni-Quatro Industries Canada, Inc. · Mar 1991
VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)
K904987 · Vibronics · Feb 1991
K910190 · BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
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