Cleared Traditional

K262044 - Mediclose Cartridge System

K262044 is an FDA 510(k) clearance for Mediclose Cartridge System, manufactured by Health Value Creation B.V., Trading AS Corporis Medical. The device is a Class 2 General & Plastic Surgery device with product code OCW cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K262044 · Health Value Creation B.V., Trading AS Corporis Medical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
119d
Days
Class 2
Risk

K262044 is an FDA 510(k) clearance for the Mediclose Cartridge System. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Health Value Creation B.V., Trading AS Corporis Medical (Maastricht, NL). The FDA issued a Cleared decision on October 14, 2026 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262044

510(k) Number K262044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2026
Decision Date October 14, 2026
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCW Device Classification - Class 2, Special Controls

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Creekside Regulatory Consulting, LLC
Allison Scott

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 70
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K262044.
Endomina EZFuse system
K252400 · Endo Tools Therapeutics S.A. · Feb 2026
SimpleStitch Suturing System
K243750 · Envision Endoscopy · Apr 2025
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
K262044 · Mediclose Cartridge System
Download PDF FDA Summary Health Value Creation…