Cleared Traditional

K022243 - HORIZONS REUSABLE HOT BIOPSY FORCEPS

K022243 is an FDA 510(k) clearance for HORIZONS REUSABLE HOT BIOPSY FORCEPS, manufactured by Horizons Intl. Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K022243 · Horizons Intl. Corp. · Gastroenterology & Urology device
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Oct 2002
Decision
105d
Days
Class 2
Risk

K022243 is an FDA 510(k) clearance for the HORIZONS REUSABLE HOT BIOPSY FORCEPS. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Horizons Intl. Corp. (Ponce, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Horizons Intl. Corp. devices

FDA 510(k) Submission Details - K022243

510(k) Number K022243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2002
Decision Date October 25, 2002
Days to Decision 105 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
26d faster than avg
Panel avg: 131d · This submission: 105d
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 40
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K022243.
MULTI-BITE HOT BIOPSY FORCEPS
K090796 · Endo-Therapeutics, Inc. · Nov 2009
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
K090583 · Apollo Endosurgery, Inc. · Jun 2009
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · Olympus Medical Systems Corporation · Dec 2006
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · Wilson-Cook Medical, Inc. · Mar 2000
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
K992390 · Telemed Systems, Inc. · Dec 1999
WILTEK HOT BIOPSY FORCEPS
K990231 · Wiltek Medical, Inc. · Apr 1999