Cleared Traditional

GRASPING FORCEPS FLEXIBLE STONE DISLODGER (K930499) - FDA 510(k) Clearance

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

K930499 · Endomedix · Gastroenterology & Urology device
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Aug 1993
Decision
196d
Days
Class 2
Risk

K930499 is an FDA 510(k) clearance for the GRASPING FORCEPS FLEXIBLE STONE DISLODGER. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Endomedix (Irvine, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 196 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 Endomedix devices

Submission Details

510(k) Number K930499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date August 16, 1993
Days to Decision 196 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
66d slower than avg
Panel avg: 130d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCZ Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.
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 - OCZ Endoscopic Grasping/cutting Instrument, Non-powered

Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K930499.
SimpleSnip Endoscopic Suture Cutter (SC500160)
K242923 · Envision Endoscopy · Dec 2024
Single Use Grasping Forceps
K191900 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2020
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
K950434 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
K881332 · Baxter Healthcare Corp · Apr 1988
DAVOL RETRIEVAL BASKETS & FORCEPS
K845017 · C.R. Bard, Inc. · Jan 1985