Cleared Traditional

K954265 - TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER...

K954265 is an FDA 510(k) clearance for TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER..., manufactured by Promex, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K954265 · Promex, Inc. · Gastroenterology & Urology device
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Sep 1995
Decision
17d
Days
Class 2
Risk

K954265 is an FDA 510(k) clearance for the TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 17 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 Promex, Inc. devices

FDA 510(k) Submission Details - K954265

510(k) Number K954265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1995
Decision Date September 29, 1995
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 130d · This submission: 17d
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 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K954265.
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K954529 · Baxter Healthcare Corp · Dec 1995
URESIL INTRODUCING NEEDLE
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MANAN SUPER-CORE BIOPSY NEEDLE
K950732 · Manan Medical Products, Inc. · Mar 1995
MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE
K944837 · Medical Device Technologies, Inc. · Oct 1994