Cleared Traditional

K052413 - TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934

K052413 is an FDA 510(k) clearance for TUNA SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K052413 · Medtronic Vascular · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
76d
Days
Class 2
Risk

K052413 is an FDA 510(k) clearance for the TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on November 17, 2005 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

FDA 510(k) Submission Details - K052413

510(k) Number K052413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2005
Decision Date November 17, 2005
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 131d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 154
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K052413.
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
K080946 · Conmed Endoscopic Technologies, Inc. · May 2008
HABIB ENDOBLATE
K072383 · Emcision , Ltd. · Nov 2007
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
K061684 · Medi-Globe Corporation · Jun 2006
OMNI SPHINCTEROTOME
K052051 · Wilson-Cook Medical, Inc. · Aug 2005
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
K050578 · Cook Ireland, Ltd. · Apr 2005
STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
K033135 · Stryker Endoscopy · Aug 2004

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.