Cleared Traditional

K200134 - Jimushi Sterile Urethral Catheter for s...

K200134 is an FDA 510(k) clearance for Jimushi Sterile Urethral Catheter for s..., manufactured by Hangzhou Jimushi Meditech Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K200134 · Hangzhou Jimushi Meditech Co., Ltd. · Gastroenterology & Urology device
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Jun 2020
Decision
132d
Days
Class 2
Risk

K200134 is an FDA 510(k) clearance for the Jimushi Sterile Urethral Catheter for single use. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Hangzhou Jimushi Meditech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 1, 2020 after a review of 132 days - within the typical 510(k) review window.

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 Hangzhou Jimushi Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K200134

510(k) Number K200134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2020
Decision Date June 01, 2020
Days to Decision 132 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
2d slower than avg
Panel avg: 130d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
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

Vee Care (Asia) Limited
Wei Shan Hsu

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 - GBM Catheter, Urethral

All 46
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