Cleared Traditional

K243750 - SimpleStitch Suturing System (FDA 510(k) Clearance)

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

K243750 · Envision Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
133d
Days
Class 2
Risk

K243750 is an FDA 510(k) clearance for the SimpleStitch Suturing System. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Envision Endoscopy (Waltham, US). The FDA issued a Cleared decision on April 17, 2025 after a review of 133 days - within the typical 510(k) review window.

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 Envision Endoscopy devices

Submission Details

510(k) Number K243750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2024
Decision Date April 17, 2025
Days to Decision 133 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
3d slower than avg
Panel avg: 130d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 - OCW Endoscopic Tissue Approximation Device

All 69
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K243750.
Endomina EZFuse system
K252400 · Endo Tools Therapeutics S.A. · Feb 2026
MaxTack™ Motorized Fixation Device
K231240 · Covidien · Sep 2023
MedicloseTM System
K213271 · Health Value Creation B.V., Trading AS Corporis Medical · Aug 2023
OverStitch NXT Endoscopic Suturing System
K231553 · Apollo Endosurgery, Inc. · Jun 2023
endomina system
K211309 · Endo Tools Therapeutics S.A. · Dec 2021
Su2ura Approximation Device
K201744 · Anchora Medical, Ltd. · Jun 2021