Cleared Traditional

K950810 - RUTNER BIOPSY DEVICE

K950810 is an FDA 510(k) clearance for RUTNER BIOPSY DEVICE, manufactured by Cook Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K950810 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
12d
Days
Class 2
Risk

K950810 is an FDA 510(k) clearance for the RUTNER BIOPSY DEVICE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 12 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 Cook Urological, Inc. devices

FDA 510(k) Submission Details - K950810

510(k) Number K950810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1995
Decision Date March 06, 1995
Days to Decision 12 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
119d faster than avg
Panel avg: 131d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

Product Code FCG Biopsy Needle
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 - FCG Biopsy Needle

All 77
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K950810.
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
K954231 · Promex, Inc. · Sep 1995
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
K954155 · Promex, Inc. · Sep 1995
B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
K950982 · B. Braun of America, Inc. · Apr 1995
GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA
K935844 · Medi-Globe Corp. · Feb 1995
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K945146 · Promex, Inc. · Dec 1994