Cleared Traditional

PROSTATIC CORE-CUT NEEDLE (K883884) - FDA 510(k) Clearance

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

K883884 · Euro-Med Intl. · Gastroenterology & Urology device
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Dec 1988
Decision
83d
Days
Class 2
Risk

K883884 is an FDA 510(k) clearance for the PROSTATIC CORE-CUT NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Euro-Med Intl. (Marlborough, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 83 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 Euro-Med Intl. devices

Submission Details

510(k) Number K883884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date December 05, 1988
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
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 99
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K883884.
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
K885169 · Boston Scientific Corp · Feb 1989
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
CAREY CAPSULE
K873996 · Wilson-Cook Medical, Inc. · Dec 1987
WILSON-COOK BIOPSY FORCEPS
K874314 · Wilson-Cook Medical, Inc. · Dec 1987