Cleared Traditional

Single Use Grasping Forceps (K191900) - FDA 510(k) Clearance

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

K191900 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Mar 2020
Decision
255d
Days
Class 2
Risk

K191900 is an FDA 510(k) clearance for the Single Use Grasping Forceps. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hanzhou, CN). The FDA issued a Cleared decision on March 27, 2020 after a review of 255 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 Zhejiang Chuangxiang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K191900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2019
Decision Date March 27, 2020
Days to Decision 255 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
125d slower than avg
Panel avg: 130d · This submission: 255d
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 11
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K191900.
KARL STORZ Endoscopic Accessories for Urology
K252800 · Karl Storz SE & CO. KG · Jun 2026
SimpleSnip Endoscopic Suture Cutter (SC500160)
K242923 · Envision Endoscopy · Dec 2024
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
K051276 · Richard Wolf Medical Instruments Corp. · Oct 2005
OLYMPUS BASKET GRASPERS (UROLOGY)
K961611 · Olympus America, Inc. · Jul 1996
OLYMPUS FG SERIES GRASPING FORCEPS
K955066 · Olympus America, Inc. · Jan 1996
OLYMPUS BASKET GRASPERS
K955063 · Olympus America, Inc. · Jan 1996