Cleared Traditional

K201776 - Foley Balloon Catheter for Urology

K201776 is the FDA 510(k) clearance for Foley Balloon Catheter for Urology by Apollon Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K201776 · Apollon Co., Ltd. · Gastroenterology & Urology device
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Dec 2020
Decision
184d
Days
Class 2
Risk

K201776 is an FDA 510(k) clearance for the Foley Balloon Catheter for Urology. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Apollon Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on December 30, 2020 after a review of 184 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Apollon Co., Ltd. devices

Submission Details

510(k) Number K201776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2020
Decision Date December 30, 2020
Days to Decision 184 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
54d slower than avg
Panel avg: 130d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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

Tsd Life Sciences Co., Ltd.
Hyeyoung Moon

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 - EZL Catheter, Retention Type, Balloon

All 58
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