Cleared Traditional

K932790 - THERMAL OPTION

K932790 is an FDA 510(k) clearance for THERMAL OPTION, 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 233-day FDA review.

K932790 · Cox Medical Ent., Inc. · Gastroenterology & Urology device
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Jan 1994
Decision
233d
Days
Class 2
Risk

K932790 is an FDA 510(k) clearance for the THERMAL OPTION. 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 January 28, 1994 after a review of 233 days - an extended review 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: 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 Cox Medical Ent., Inc. devices

FDA 510(k) Submission Details - K932790

510(k) Number K932790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date January 28, 1994
Days to Decision 233 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
103d slower than avg
Panel avg: 130d · This submission: 233d
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 K932790.
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
HOT BIOPSY FORCEPS
K910964 · Symbiosis Corp. · May 1991