Cleared Traditional

K970764 - COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES

K970764 is an FDA 510(k) clearance for COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES, manufactured by Comeg Endoscopy. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K970764 · Comeg Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
50d
Days
Class 2
Risk

K970764 is an FDA 510(k) clearance for the COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Comeg Endoscopy (Aurora, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Comeg Endoscopy devices

FDA 510(k) Submission Details - K970764

510(k) Number K970764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date April 22, 1997
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCX Device Classification - Class 2, Special Controls

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
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 - OCX Endoscopic Irrigation/suction System

All 66
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K970764.
KSEA QUADRO SWITCH
K021776 · Karl Storz Endoscopy · Aug 2002
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K993778 · Northgate Technologies, Inc. · Jan 2000
ENDIUS SUCTION/IRRIGATION INSTRUMENT
K992535 · Endius, Inc. · Sep 1999
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
K964196 · Northgate Technologies, Inc. · Dec 1996
J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS
K953655 · Johnson & Johnson Medical, Inc. · Oct 1995
BARD(R) SYRINGE ASSIST IRRIGATION
K905102 · C.R. Bard, Inc. · Apr 1991