Cleared Traditional

Saneso Lens Wash Bottle Assembly (SAN-LWB-A) (K222173) - FDA 510(k) Clearance

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

K222173 · Saneso, Inc. · Gastroenterology & Urology device
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Feb 2023
Decision
221d
Days
Class 2
Risk

K222173 is an FDA 510(k) clearance for the Saneso Lens Wash Bottle Assembly (SAN-LWB-A). Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Saneso, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 27, 2023 after a review of 221 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 Saneso, Inc. devices

Submission Details

510(k) Number K222173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2022
Decision Date February 27, 2023
Days to Decision 221 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
91d slower than avg
Panel avg: 130d · This submission: 221d
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 Consultant

Elexes Medical Consulting, LLC
Parul Chansoria

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 46
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K222173.
ENDOGATOR™ Hybrid Irrigation Tubing
K231418 · Medivators · Aug 2023
Protego Air Water Connector
K231602 · Ga Health Company Limited · Aug 2023
ANDORATE® Valve Kit
K230932 · Ga Health Company Limited · Jul 2023
troCarWash™ System
K222695 · Biotex, Inc. · Feb 2023
AquaPulse® Irrigation Tubing
K223171 · Ga Health Company Limited · Nov 2022
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
K222734 · Diversatek Healthcare · Nov 2022