Cleared Traditional

K260110 - danumed Extension Set for Gastrostomy Button

K260110 is an FDA 510(k) clearance for danumed Extension Set for Gastrostomy B..., manufactured by Danumed Medizintechnik GmbH. The device is a Class 2 Gastroenterology & Urology device with product code PIF cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K260110 · Danumed Medizintechnik GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
239d
Days
Class 2
Risk

K260110 is an FDA 510(k) clearance for the danumed Extension Set for Gastrostomy Button. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Danumed Medizintechnik GmbH (Regensburg, DE). The FDA issued a Cleared decision on September 10, 2026 after a review of 239 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Danumed Medizintechnik GmbH devices

FDA 510(k) Submission Details - K260110

510(k) Number K260110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2026
Decision Date September 10, 2026
Days to Decision 239 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
108d slower than avg
Panel avg: 131d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PIF Device Classification - Class 2, Special Controls

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
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 - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 51
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K260110.
Edi Catheter ENFit 6Fr/48 cm (6893166)
K253715 · Maquet Critical Care AB · Aug 2026
Percutaneous Endoscopic Gastrostomy (PEG) Kit
K254170 · Degania Silicone , Ltd. · Mar 2026
Enteral Drainage System, Enteral Medicine straw
K242917 · Hmc Premedical S.P.A. · Jun 2025
Extension Feeding Set with ENFit™ Connectors
K250481 · SKY Medical, a.s. · Apr 2025
Disposable Enteral Feeding Sets
K240052 · Beijing L&Z Medical Technology Development Co., Ltd. · Jul 2024
Mobility+ Enteral Feeding System OTC
K233034 · Rockfield Medical · Apr 2024