Cleared Traditional

KARL STORZ Endoscopic Accessories for Urology (K252800) - FDA 510(k) Clearance

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

K252800 · Karl Storz SE & CO. KG · Gastroenterology & Urology device
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Jun 2026
Decision
273d
Days
Class 2
Risk

K252800 is an FDA 510(k) clearance for the KARL STORZ Endoscopic Accessories for Urology. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on June 3, 2026 after a review of 273 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 Karl Storz SE & CO. KG devices

Submission Details

510(k) Number K252800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2025
Decision Date June 03, 2026
Days to Decision 273 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
143d slower than avg
Panel avg: 130d · This submission: 273d
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

All 73
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K252800.
SimpleSnip Endoscopic Suture Cutter (SC500160)
K242923 · Envision Endoscopy · Dec 2024
Single Use Grasping Forceps
K191900 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2020
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
K881332 · Baxter Healthcare Corp · Apr 1988
DAVOL RETRIEVAL BASKETS & FORCEPS
K845017 · C.R. Bard, Inc. · Jan 1985