Cleared Traditional

K151745 - FULL CARE Disposable PVC Nelaton Catheter

K151745 is an FDA 510(k) clearance for FULL CARE Disposable PVC Nelaton Catheter, manufactured by Shaoxing Fuqing Health Products Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K151745 · Shaoxing Fuqing Health Products Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
248d
Days
Class 2
Risk

K151745 is an FDA 510(k) clearance for the FULL CARE Disposable PVC Nelaton Catheter. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Shaoxing Fuqing Health Products Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on March 3, 2016 after a review of 248 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 Shaoxing Fuqing Health Products Co., Ltd. devices

FDA 510(k) Submission Details - K151745

510(k) Number K151745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2015
Decision Date March 03, 2016
Days to Decision 248 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
117d slower than avg
Panel avg: 131d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

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

Guangzhou Osmunda Medical Device Technology Service Co., Ltd.
MIKE GU

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 78
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