Cleared Special

K161315 - Vein Clamps, Artery Clamps

K161315 is an FDA 510(k) clearance for Vein Clamps, manufactured by Aros Surgical Instruments Corporation. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Special 510(k) pathway after a 99-day FDA review.

K161315 · Aros Surgical Instruments Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
99d
Days
Class 2
Risk

K161315 is an FDA 510(k) clearance for the Vein Clamps, Artery Clamps. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Aros Surgical Instruments Corporation (Newport Beach, US). The FDA issued a Cleared decision on August 18, 2016 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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. Standard predicate reliance. 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 - K161315

510(k) Number K161315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2016
Decision Date August 18, 2016
Days to Decision 99 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Specialist, Inc.
Greg Holland

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 - DXC Clamp, Vascular

All 192
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K161315.
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TR BAND Radial Compression Device
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