Cleared Traditional

K813085 - HEPAFIX BIOPSY NEEDLE SET

K813085 is an FDA 510(k) clearance for HEPAFIX BIOPSY NEEDLE SET, manufactured by Burron Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K813085 · Burron Medical Products, Inc. · Gastroenterology & Urology device
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Nov 1981
Decision
18d
Days
Class 2
Risk

K813085 is an FDA 510(k) clearance for the HEPAFIX BIOPSY NEEDLE SET. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1981 after a review of 18 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 Burron Medical Products, Inc. devices

FDA 510(k) Submission Details - K813085

510(k) Number K813085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1981
Decision Date November 20, 1981
Days to Decision 18 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
113d faster than avg
Panel avg: 131d · This submission: 18d
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 224
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K813085.
MANAN WESTCOTT NEEDLE
K851837 · Manan Manufacturing Co., Inc. · May 1985
FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP
K851364 · Precision Dynamics Corp. · Apr 1985
BONE BIOPSY SET
K820293 · The Anspach Effort, Inc. · Mar 1982
VANCE PROSTATIC ASPIRATION SET
K811454 · Vance Products, Inc. · Jun 1981
HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM
K781038 · Quinton, Inc. · Aug 1978
PROSTATE BIOPSY NEEDLE
K770122 · Cook, Inc. · Jan 1977