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PK AIM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170908

by Gyrus Acmi, Inc.

Identifiers

510(k) Number
K170908 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PK AIM is a vascular sealing device designed for the sealing of arteries, veins, and artery-vein bundles up to 3 mm in diameter. Classified under product code GEI (General, Plastic Surgery), it employs a technology comparable to the predicate device for precise tissue coagulation and division during surgical procedures. Its primary function is to provide a controlled, atraumatic seal to minimize bleeding and reduce operative time in minimally invasive and open surgical applications.

The PK AIM is supplied as a single-use device, intended for use in sterile surgical environments. It is regulated under FDA 510(k) clearance (K170908), with a decision date of May 19, 2017, and is intended for use in general and plastic surgery settings. No MRI safety information is specified, and storage conditions are not detailed in the regulatory submission. The device is distributed by Gyrus Acmi, Inc., and its design is substantiated as substantially equivalent to the predicate device.

Frequently asked questions

What is the PK AIM vascular sealer designed to seal?

The PK AIM is specifically designed for sealing arteries, veins, and artery-vein bundles with diameters up to 3 millimeters. Its technology ensures precise tissue coagulation and division, helping to minimize bleeding and shorten surgical time during procedures.

Is the PK AIM device single-use or reusable?

The PK AIM is supplied as a single-use device, intended for use in sterile surgical environments only. This design ensures patient safety by preventing cross-contamination and maintaining sterility for each surgical procedure.

What type of surgical procedures is the PK AIM intended for?

The PK AIM is intended for use in both minimally invasive and open surgical applications within general and plastic surgery settings. Its atraumatic sealing technology is particularly useful in procedures where reducing bleeding and operative time are critical.

Are there specific storage instructions for the PK AIM?

The regulatory submission for the PK AIM does not specify detailed storage conditions. Clinicians should follow standard sterile surgical equipment storage protocols to maintain device integrity until use.

How does the PK AIM compare to its predicate device?

The PK AIM’s design is substantiated as substantially equivalent to its predicate device, meaning it shares the same intended use and technology principles while maintaining regulatory compliance under FDA 510(k) clearance (K170908).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K170908 - PK AIM | FDA 510 (k) | Gyrus Acmi, Inc., Pk Aim 510 (k) FDA Premarket Notification K152219 GYRUS ACMI INC, PK AIM (K161825) — FDA 510 (k) | Innolitics, Pk Aim 510 (k) FDA Premarket Notification K163373 Gyrus ACMI Inc., PDF Gyrus ACMI Ureteroscopes - accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA 510(k) K170908 24 fields · synced Oct 1, 2026