Cleared Traditional

K940911 - BASICS ENDOSCOPY SYSTEM

K940911 is an FDA 510(k) clearance for BASICS ENDOSCOPY SYSTEM, manufactured by Cox Medical Ent., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K940911 · Cox Medical Ent., Inc. · Gastroenterology & Urology device
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May 1994
Decision
80d
Days
Class 2
Risk

K940911 is an FDA 510(k) clearance for the BASICS ENDOSCOPY SYSTEM. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Cox Medical Ent., Inc. (Ventura, US). The FDA issued a Cleared decision on May 16, 1994 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Cox Medical Ent., Inc. devices

FDA 510(k) Submission Details - K940911

510(k) Number K940911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1994
Decision Date May 16, 1994
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGE Device Classification - Class 2, Special Controls

Product Code KGE Forceps, Biopsy, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KGE Forceps, Biopsy, Electric

All 29
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K940911.
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K955052 · Olympus America, Inc. · Jan 1996
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445 · Olympus America, Inc. · May 1995
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
K944765 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
K932266 · Symbiosis Corp. · Mar 1994
DISPOSABLE HOT BIOPSY FORCEPS
K923470 · Wilson-Cook Medical, Inc. · Apr 1993
BIOPSY FORCEPS, ELECTRIC
K925361 · United States Endoscopy Group, Inc. · Mar 1993