Cleared Traditional

K202566 - Wiygul Catheter

K202566 is the FDA 510(k) clearance for Wiygul Catheter by Big Blue Biotech, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZD) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K202566 · Big Blue Biotech, Inc. · Gastroenterology & Urology device
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Sep 2020
Decision
26d
Days
Class 2
Risk

K202566 is an FDA 510(k) clearance for the Wiygul Catheter. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Big Blue Biotech, Inc. (Canton, US). The FDA issued a Cleared decision on September 30, 2020 after a review of 26 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Big Blue Biotech, Inc. devices

Submission Details

510(k) Number K202566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2020
Decision Date September 30, 2020
Days to Decision 26 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
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code EZD Catheter, Straight
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

Regulatory Technology Services, LLC
Prithul Bom

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 - EZD Catheter, Straight

All 47
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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.