Cleared Traditional

SimpleSnip Endoscopic Suture Cutter (SC500160) (K242923) - FDA 510(k) Clearance

Also marketed or referenced as:
SimpleSnip Endoscopic Suture Cutter (SC500230)

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

K242923 · Envision Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
87d
Days
Class 2
Risk

K242923 is an FDA 510(k) clearance for the SimpleSnip Endoscopic Suture Cutter (SC500160). Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Envision Endoscopy (Waltham, US). The FDA issued a Cleared decision on December 20, 2024 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Envision Endoscopy devices

Submission Details

510(k) Number K242923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2024
Decision Date December 20, 2024
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 K242923.
KARL STORZ Endoscopic Accessories for Urology
K252800 · Karl Storz SE & CO. KG · Jun 2026
Single Use Grasping Forceps
K191900 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2020
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