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Orthopilot 2

by Aesculap, Inc.

510(k) K013569

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013569 Date4 Apr 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HAW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Orthopilot 2 is a neurology device classified under product code HAW. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The device was cleared by the FDA on April 4, 2002, under K013569. It is manufactured by Aesculap, Inc. and is intended for use in neurology applications as indicated by the advisory committee classification.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Orthopilot 2 used for?

    The Orthopilot 2 is intended for use in neurology applications, as indicated by its advisory committee classification under product code HAW, which identifies devices in the neurology specialty.

  • How was the Orthopilot 2 cleared for market?

    The Orthopilot 2 was cleared by the FDA on April 4, 2002, under K013569 through the traditional 510(k) pathway as a substantially equivalent device, meaning it demonstrated safety and effectiveness comparable to a legally marketed predicate device.

  • Who manufactures the Orthopilot 2 and where is it made?

    The Orthopilot 2 is manufactured by Aesculap, Inc., located at 3773 Corporate Pkwy., Center Valley, PA 18034, United States, as specified in the device’s authorization and applicant information.