Cleared Traditional

K192498 - Single Use Injector

K192498 is the FDA 510(k) clearance for Single Use Injector by Olympus Medical Systems Corp.. It is a Class 2 Gastroenterology & Urology device (product code FBK) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K192498 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Apr 2020
Decision
230d
Days
Class 2
Risk

K192498 is an FDA 510(k) clearance for the Single Use Injector. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on April 28, 2020 after a review of 230 days - an extended review cycle.

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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K192498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2019
Decision Date April 28, 2020
Days to Decision 230 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
100d slower than avg
Panel avg: 130d · This submission: 230d
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 Consultant

Olympus Corporation of the Americas
Sheri L. Musgnung

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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 48
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K192498.
Endoscopic Injection Needle
K213239 · Beijing Zksk Technology Co., Ltd. · Jun 2022
Sclerotherapy Needle
K212668 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Feb 2022
Single Use Injection Needle
K210917 · Anrei Medical (Hangzhou) Co., Ltd. · May 2021
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