Cleared Traditional

K261447 - CVAC® Aspiration System

K261447 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 FGB cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K261447 · Calyxo, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
137d
Days
Class 2
Risk

K261447 is an FDA 510(k) clearance for the CVAC® Aspiration System. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Calyxo, Inc. (Pleasanton, US). The FDA issued a Cleared decision on September 15, 2026 after a review of 137 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 Calyxo, Inc. devices

FDA 510(k) Submission Details - K261447

510(k) Number K261447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2026
Decision Date September 15, 2026
Days to Decision 137 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
6d slower than avg
Panel avg: 131d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGB Device Classification - Class 2, Special Controls

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FGB Ureteroscope And Accessories, Flexible/rigid

All 111
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K261447.
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
K262488 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Sep 2026
LithoVue Elite Digital Flexible Ureteroscope System
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K262552 · Scivita Medical Technology Co., Ltd. · Aug 2026
Zamenix™ P
K253505 · Roen Surgical, Inc. · Aug 2026
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K260516 · MacroLux Medical Technology Co., Ltd. · Jul 2026
Single Use Digital Flexible Ureteroscope (7.5F)
K252929 · Anhui Happiness Workshop Instruments Co., Ltd. · Apr 2026