Cleared Traditional

Repris Bladder Injection System (K180214) - FDA 510(k) Clearance

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

K180214 · Uro-1, Inc. · Gastroenterology & Urology device
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May 2018
Decision
98d
Days
Class 2
Risk

K180214 is an FDA 510(k) clearance for the Repris Bladder Injection System. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Uro-1, Inc. (Winston Salem, US). The FDA issued a Cleared decision on May 3, 2018 after a review of 98 days - within the typical 510(k) review window.

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 Uro-1, Inc. devices

Submission Details

510(k) Number K180214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2018
Decision Date May 03, 2018
Days to Decision 98 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
32d faster than avg
Panel avg: 130d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 Peers - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 35
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K180214.
Disposable Sclerotherapy Needle
K190032 · Hangzhou AGS MedTech Co., Ltd. · Feb 2020
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
K190829 · Wilson-Cook Medical Inc./Cook Endoscopy · Dec 2019
Clear-Jet Injection Catheter
K181690 · Finemedix Co., Ltd. · Dec 2018
Williams Cystoscopic Injection Needle
K171602 · Cook Incorporated · Jul 2017
Interject Injection Therapy Needle Catheter
K171454 · Boston Scientific Corporation · Jul 2017
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
K111495 · Wilson-Cook Medical, Inc. · Jul 2011