Cleared Traditional

K854291 - MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY

K854291 is an FDA 510(k) clearance for MED SURG PERCUTANEOUS ASPIRATION BIOPSY..., manufactured by Medsurg Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K854291 · Medsurg Industries, Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
32d
Days
Class 2
Risk

K854291 is an FDA 510(k) clearance for the MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on November 26, 1985 after a review of 32 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 Medsurg Industries, Inc. devices

FDA 510(k) Submission Details - K854291

510(k) Number K854291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date November 26, 1985
Days to Decision 32 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
99d faster than avg
Panel avg: 131d · This submission: 32d
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 K854291.
UROCUT BIOPSY NEEDLE
K861267 · Meadox Surgimed, Inc. · Jan 1987
MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT
K864329 · Dlp, Inc. · Dec 1986
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · Travenol Laboratories, S.A. · Feb 1986
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM
K854297 · Medsurg Industries, Inc. · Nov 1985
MANAN MENGHINI NEEDLE
K851836 · Manan Manufacturing Co., Inc. · Jun 1985
MANAN CHIBA PTC NEEDLE
K851838 · Manan Manufacturing Co., Inc. · Jun 1985