Cleared Traditional

ENDOtube (K203350) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203350 · Nissha Medical Technologies Sas · Gastroenterology & Urology device
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Sep 2021
Decision
320d
Days
Class 2
Risk

K203350 is an FDA 510(k) clearance for the ENDOtube. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Nissha Medical Technologies Sas (Conflans Ste Honorine, FR). The FDA issued a Cleared decision on September 29, 2021 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Nissha Medical Technologies Sas devices

Submission Details

510(k) Number K203350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2020
Decision Date September 29, 2021
Days to Decision 320 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
190d slower than avg
Panel avg: 130d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 46
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K203350.
OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315
K221824 · Cipher Surgical Limited · Aug 2022
Erbe's Tubing/Cap Sets
K221177 · Erbe USA, Inc. · Aug 2022
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
K210618 · Chongqing Jinshan Science & Technology Co., Ltd. · Oct 2021
ClearCap Distal Attachment
K202616 · Finemedix Co., Ltd. · Feb 2021
AquaPulse Irrigation Tubing
K202560 · Ga Health Company Limited · Dec 2020
AquaPulse Auxiliary Water Connector
K200479 · Ga Health Company Limited · May 2020