Cleared Traditional

K935844 - GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRAS...

K935844 is an FDA 510(k) clearance for GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRAS..., manufactured by Medi-Globe Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 432-day FDA review.

K935844 · Medi-Globe Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
432d
Days
Class 2
Risk

K935844 is an FDA 510(k) clearance for the GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Medi-Globe Corp. (Tempe, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 432 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Medi-Globe Corp. devices

FDA 510(k) Submission Details - K935844

510(k) Number K935844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1993
Decision Date February 13, 1995
Days to Decision 432 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 130d · This submission: 432d
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 55
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K935844.
DAUM BIOPSYNEEDLE
K961185 · Ferguson Medical · Apr 1996
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K943304 · Olympus America, Inc. · Dec 1995
RUTNER BIOPSY DEVICE
K950810 · Cook Urological, Inc. · Mar 1995
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
WILSON-COOK GI ASPIRATION NEEDLE
K934356 · Wilson-Cook Medical, Inc. · Jan 1994
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · C.R. Bard, Inc. · Jun 1991