Cleared Traditional

K160861 - Proxis Ureteral Access Sheath

K160861 is an FDA 510(k) clearance for Proxis Ureteral Access Sheath, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 2-day FDA review.

K160861 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
2d
Days
Class 2
Risk

K160861 is an FDA 510(k) clearance for the Proxis Ureteral Access Sheath. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on March 31, 2016 after a review of 2 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. 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.

FDA 510(k) Submission Details - K160861

510(k) Number K160861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2016
Decision Date March 31, 2016
Days to Decision 2 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
129d faster than avg
Panel avg: 131d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 100
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K160861.
Arc EndoCuff and Arc EndoCuff Vision
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K160846 · Medivators, Inc. · Jul 2016
Well Lead Ureteral Access Sheath
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Arc Endocuff Vision
K151801 · Boddingtons Plastics, Ltd. · Aug 2015
Sidecar External Working Channel
K150083 · C2 Therapeutics · Apr 2015

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.

K160861 · Proxis Ureteral Access Sheath
Download PDF FDA Summary C.R. Bard, Inc.