Cleared Traditional

ENTERON LIVER BIOPSY TRAY (K874062) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874062 · Endovations · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
87d
Days
Class 2
Risk

K874062 is an FDA 510(k) clearance for the ENTERON LIVER BIOPSY TRAY. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on December 31, 1987 after a review of 87 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 Endovations devices

Submission Details

510(k) Number K874062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1987
Decision Date December 31, 1987
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K874062.
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
K884900 · Siemens Medical Solutions USA, Inc. · Jan 1989
BARD(R) ASPIRATION BIOPSY SYSTEM
K883469 · C.R. Bard, Inc. · Jan 1989
BARD BIOPSY NEEDLE GUIDANCE DEVICE
K883374 · C.R. Bard, Inc. · Sep 1988
BARD BIOPTY BIOPSY SYSTEM
K871390 · C.R. Bard, Inc. · Jun 1987
SOFT TISSUE BIOPSY NEEDLE
K870785 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · Travenol Laboratories, S.A. · Feb 1986