Cleared Traditional

ClearCap Distal Attachment (K202616) - FDA 510(k) Clearance

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

K202616 · Finemedix Co., Ltd. · Gastroenterology & Urology device
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Feb 2021
Decision
163d
Days
Class 2
Risk

K202616 is an FDA 510(k) clearance for the ClearCap Distal Attachment. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Finemedix Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 19, 2021 after a review of 163 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 Finemedix Co., Ltd. devices

Submission Details

510(k) Number K202616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2020
Decision Date February 19, 2021
Days to Decision 163 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
33d slower than avg
Panel avg: 130d · This submission: 163d
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

Withus Group, Inc.
April Lee

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 K202616.
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
ENDOtube
K203350 · Nissha Medical Technologies Sas · Sep 2021
AquaPulse Irrigation Tubing
K202560 · Ga Health Company Limited · Dec 2020
AquaPulse Auxiliary Water Connector
K200479 · Ga Health Company Limited · May 2020
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
K200388 · Ga Health Company Limited · Apr 2020