Cleared Traditional

K883469 - BARD(R) ASPIRATION BIOPSY SYSTEM

K883469 is an FDA 510(k) clearance for BARD ASPIRATION BIOPSY SYSTEM, 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 144-day FDA review.

K883469 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Jan 1989
Decision
144d
Days
Class 2
Risk

K883469 is an FDA 510(k) clearance for the BARD(R) ASPIRATION BIOPSY SYSTEM. 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 January 6, 1989 after a review of 144 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 - K883469

510(k) Number K883469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1988
Decision Date January 06, 1989
Days to Decision 144 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
13d slower than avg
Panel avg: 131d · This submission: 144d
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 K883469.
ADMS SILENT NEEDLE GUN
K882746 · Advanced Diagnostic Medical Systems, Inc. · Mar 1989
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
K885169 · Boston Scientific Corp · Feb 1989
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
K884900 · Siemens Medical Solutions USA, Inc. · Jan 1989
PROSTATIC CORE-CUT NEEDLE
K883884 · Euro-Med Intl. · Dec 1988
BARD BIOPSY NEEDLE GUIDANCE DEVICE
K883374 · C.R. Bard, Inc. · Sep 1988
NATIONAL-STANDARD NEEDLE HOLDER
K881956 · N-S Medical Products · May 1988
K883469 · BARD(R) ASPIRATION BIOPSY SYSTEM
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