Cleared Traditional

K080946 - CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX

K080946 is an FDA 510(k) clearance for CONMED AXCESS PAPILLOTOME MODELS AX4535, manufactured by Conmed Endoscopic Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K080946 · Conmed Endoscopic Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
47d
Days
Class 2
Risk

K080946 is an FDA 510(k) clearance for the CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Conmed Endoscopic Technologies, Inc. (Billerica, US). The FDA issued a Cleared decision on May 20, 2008 after a review of 47 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 Conmed Endoscopic Technologies, Inc. devices

FDA 510(k) Submission Details - K080946

510(k) Number K080946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2008
Decision Date May 20, 2008
Days to Decision 47 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
84d faster than avg
Panel avg: 131d · This submission: 47d
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

Intertek Testing Services
DANIEL W LEHTONEN

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 157
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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.