Cleared Traditional

K183428 - Avulsion Forceps

K183428 is the FDA 510(k) clearance for Avulsion Forceps by STERIS Corporation. It is a Class 2 Gastroenterology & Urology device (product code KGE) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K183428 · STERIS Corporation · Gastroenterology & Urology device
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Apr 2019
Decision
126d
Days
Class 2
Risk

K183428 is an FDA 510(k) clearance for the Avulsion Forceps. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 16, 2019 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 STERIS Corporation devices

Submission Details

510(k) Number K183428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2018
Decision Date April 16, 2019
Days to Decision 126 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
4d faster than avg
Panel avg: 130d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGE Forceps, Biopsy, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KGE Forceps, Biopsy, Electric

All 25
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K183428.
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053 · Fujifilm Corporation · Feb 2022
Bipolar Coagulation Foreceps
K210406 · Hangzhou AGS MedTech Co., Ltd. · Oct 2021
Ensure Single-Use Coagulation Forceps
K202438 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2021
Disposable Hot Biopsy Forceps
K180018 · Micro-Tech (Nanjing) Co., Ltd. · Jul 2018
Ensizor Monopolar Endoscopic Scissors
K180134 · Slater Endoscopy, LLC · Jun 2018
Captura® Disposable Hot Biopsy Forceps
K171973 · Wilson-Cook Medical, Inc. · Mar 2018