Cleared Special

K260965 - CVAC Aspiration System

K260965 is an FDA 510(k) clearance for CVAC Aspiration System, manufactured by Calyxo, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Special 510(k) pathway after a 21-day FDA review.

K260965 · Calyxo, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
21d
Days
Class 2
Risk

K260965 is an FDA 510(k) clearance for the CVAC Aspiration System. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Calyxo, Inc. (Pleasanton, US). The FDA issued a Cleared decision on April 13, 2026 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K260965

510(k) Number K260965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2026
Decision Date April 13, 2026
Days to Decision 21 days
Submission Type Special
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
110d faster than avg
Panel avg: 131d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 103
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K260965.
Pathfinder Endoscope Overtube
K262262 · Neptune Medical, Inc. · Sep 2026
Single Use Ureteral Access Sheath
K260410 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Sep 2026
Navigator™ Flex Ureteral Access Sheath Set
K261915 · Boston Scientific Corporation · Aug 2026
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
K260521 · Zhuhai Pusen Medical Technology Co., Ltd. · Apr 2026
Prodeon Urethral Sheath System
K252572 · Prodeon Medical, Inc. · Oct 2025
Single Use Suction-Evacuation Ureteral Access Sheath
K250128 · Anhui Happiness Workshop Medical Instruments Co., Ltd. · Sep 2025
K260965 · CVAC Aspiration System
Download PDF FDA Summary Calyxo, Inc.