Cleared Traditional

K974158 - ORION MEDICAL INC. DISPOSABLE BRAIN BIO...

K974158 is the FDA 510(k) clearance for ORION MEDICAL INC. DISPOSABLE BRAIN BIO... by Ortho Development Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K974158 · Ortho Development Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
36d
Days
Class 2
Risk

K974158 is an FDA 510(k) clearance for the ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on December 9, 1997 after a review of 36 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 Ortho Development Corp. devices

Submission Details

510(k) Number K974158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1997
Decision Date December 09, 1997
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 130d · This submission: 36d
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 156
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K974158.
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K980004 · Medical Device Technologies, Inc. · Jan 1998
MANAN AUTOMATIC CUTTING NEEDLE
K974446 · Manan Medical Products, Inc. · Jan 1998
MANAN TECHNA-CUT ASPIRATION NEEDLE
K974766 · Medical Device Technologies, Inc. · Jan 1998
THE AUTO SUTURE* MIBB** SYSTEM
K973496 · United States Surgical, A Division of Tyco Healthc · Dec 1997
QUICK-CARE BIOPSY NEEDLE
K973565 · Cook, Inc. · Nov 1997
MRI COMPATIBLE BIOPSY NEEDLES
K962977 · Manan Medical Products, Inc. · Oct 1997