Cleared Traditional

K182998 - Andorate Auxiliary Water Connector

K182998 is the FDA 510(k) clearance for Andorate Auxiliary Water Connector by Smartdata Suzhou Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code OCX) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K182998 · Smartdata Suzhou Co., Ltd. · Gastroenterology & Urology device
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Apr 2019
Decision
169d
Days
Class 2
Risk

K182998 is an FDA 510(k) clearance for the Andorate Auxiliary Water Connector. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Smartdata Suzhou Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on April 17, 2019 after a review of 169 days - an extended review 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: 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 Smartdata Suzhou Co., Ltd. devices

Submission Details

510(k) Number K182998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2018
Decision Date April 17, 2019
Days to Decision 169 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 130d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 58
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K182998.
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ERBEFLO Olympus Scope Port Connector
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K182275 · Boston Scientific Corporation · Sep 2018

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.