Cleared Traditional

MULTI-BITE HOT BIOPSY FORCEPS (K090796) - FDA 510(k) Clearance

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

K090796 · Endo-Therapeutics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
246d
Days
Class 2
Risk

K090796 is an FDA 510(k) clearance for the MULTI-BITE HOT BIOPSY FORCEPS. Classified as Forceps, Biopsy, Electric (product code KGE), Class II - Special Controls.

Submitted by Endo-Therapeutics, Inc. (Clearwater, US). The FDA issued a Cleared decision on November 25, 2009 after a review of 246 days - an extended review cycle.

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 Endo-Therapeutics, Inc. devices

Submission Details

510(k) Number K090796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2009
Decision Date November 25, 2009
Days to Decision 246 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 130d · This submission: 246d
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 45
Devices cleared under the same product code (KGE) and FDA review panel - the closest regulatory comparables to K090796.
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
K251807 · Olympus Medical Systems Corp. · Mar 2026
Disposable Hot Biopsy Forceps (FD-210U)
K250187 · Olympus Medical Systems Corporation · Oct 2025
ClearHemograsper
K242857 · Finemedix Co., Ltd. · May 2025
Disposable Hot Biopsy Forceps
K231721 · Beijing Zksk Technology Co., Ltd. · Dec 2023
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053 · Fujifilm Corporation · Feb 2022
Bipolar Coagulation Foreceps
K210406 · Hangzhou AGS MedTech Co., Ltd. · Oct 2021