Cleared Traditional

K992535 - ENDIUS SUCTION/IRRIGATION INSTRUMENT

K992535 is an FDA 510(k) clearance for ENDIUS SUCTION/IRRIGATION INSTRUMENT, manufactured by Endius, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K992535 · Endius, Inc. · Gastroenterology & Urology device
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Sep 1999
Decision
34d
Days
Class 2
Risk

K992535 is an FDA 510(k) clearance for the ENDIUS SUCTION/IRRIGATION INSTRUMENT. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Endius, Inc. (Plainville, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 34 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 Endius, Inc. devices

FDA 510(k) Submission Details - K992535

510(k) Number K992535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1999
Decision Date September 01, 1999
Days to Decision 34 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 131d · This submission: 34d
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 81
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K992535.
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K993778 · Northgate Technologies, Inc. · Jan 2000
ENDO SMARTCAP (100501)
K971125 · Endo Smart Cap Co. · May 1997
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
K970764 · Comeg Endoscopy · Apr 1997
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
K964196 · Northgate Technologies, Inc. · Dec 1996