Cleared Traditional

K855003 - BERAHA BIOPSY NEEDLES

K855003 is the FDA 510(k) clearance for BERAHA BIOPSY NEEDLES by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K855003 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Feb 1986
Decision
59d
Days
Class 2
Risk

K855003 is an FDA 510(k) clearance for the BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on February 10, 1986 after a review of 59 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K855003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1985
Decision Date February 10, 1986
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
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 160
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K855003.
PROSTATIC ASPIRATION BIOPSY SET
K870735 · Van-Tec, Inc. · Mar 1987
TEFLON BIOPSY CATHETER W/TIP ANGLE
K870734 · Van-Tec, Inc. · Mar 1987
MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT
K864329 · Dlp, Inc. · Dec 1986
MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY
K854291 · Medsurg Industries, Inc. · Nov 1985
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM
K854297 · Medsurg Industries, Inc. · Nov 1985
53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN
K851798 · Artiberia · May 1985