Cleared Traditional

K090583 - ENDOSCOPIC MONOPOLAR SCISSORS

K090583 is an FDA 510(k) clearance for ENDOSCOPIC MONOPOLAR SCISSORS, manufactured by Apollo Endosurgery, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KGE cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K090583 · Apollo Endosurgery, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
114d
Days
Class 2
Risk

K090583 is an FDA 510(k) clearance for the ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Cleared decision on June 26, 2009 after a review of 114 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 Apollo Endosurgery, Inc. devices

FDA 510(k) Submission Details - K090583

510(k) Number K090583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2009
Decision Date June 26, 2009
Days to Decision 114 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 130d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGE Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K090583.
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474 · Fujifilm Medical System U.S.A., Inc. · Feb 2016
ENDOCHOICE HOT BIOPSY FORCEPS
K131991 · Endochoice, Inc. · Oct 2013
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · Boston Scientific Corp · Oct 2010
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · Olympus Medical Systems Corporation · Dec 2006
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · Wilson-Cook Medical, Inc. · Mar 2000
UNIPOLAR OPTICAL BIOPSY FORCEPS
K983811 · Olympus Winter & Ibe GmbH · Dec 1998