Cleared Traditional

K870785 - SOFT TISSUE BIOPSY NEEDLE

K870785 is an FDA 510(k) clearance for SOFT TISSUE BIOPSY NEEDLE, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K870785 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Gastroenterology & Urology device
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Apr 1987
Decision
34d
Days
Class 2
Risk

K870785 is an FDA 510(k) clearance for the SOFT TISSUE BIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 1, 1987 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K870785

510(k) Number K870785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date April 01, 1987
Days to Decision 34 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
97d faster than avg
Panel avg: 131d · This submission: 34d
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 304
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K870785.
SECURLINE FRANSEENE NEEDLE
K873369 · Precision Dynamics Corp. · Oct 1987
MANAN TURNER STYLE NEEDLE
K873208 · Manan Manufacturing Co., Inc. · Aug 1987
BARD BIOPTY BIOPSY SYSTEM
K871390 · C.R. Bard, Inc. · Jun 1987
PROSTATIC ASPIRATION BIOPSY SET
K870735 · Van-Tec, Inc. · Mar 1987
TEFLON BIOPSY CATHETER W/TIP ANGLE
K870734 · Van-Tec, Inc. · Mar 1987
UROCUT BIOPSY NEEDLE
K861267 · Meadox Surgimed, Inc. · Jan 1987