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Linasys

by Pathfinder Therapeutics, Inc.

510(k) K071063

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Overview

LINASYS is a neurology-specific medical device used during intraoperative procedures. Developed by Pathfinder Therapeutics, Inc., it has been substantively equivalent to other devices in its class and is approved for use in the United States. Designed for minimally invasive surgery, LINASYS provides accurate tracking of tissue and neural structures, enhancing surgical precision and reducing post-operative complications.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071063 Date20 Dec 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
OEW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Pathfinder Therapeutics, Inc.