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Norapad Plain; Norapad Ta

by Perlei Medical, Inc.

510(k) K014268

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

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK014268 Date27 Mar 2002ClearedStatusActive

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  • Withdrawn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
HBA
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 882.4700
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Norapad Plain and Norapad Ta are neurosurgical paddies. They are classified as class 2 devices. The device name indicates that they are used in neurology.

The devices are supplied by Perlei Medical, Inc. and have a product code of HBA. They have a regulation number of 882.4700 and are substantially equivalent. The devices have been authorized with an FDA 510K clearance.

Questions

AI-generated answers, 23 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 are the Norapad Plain and Norapad Ta used for?

    The Norapad Plain and Norapad Ta are used in neurology as neurosurgical paddies.

  • Who supplies the Norapad devices?

    The Norapad devices are supplied by Perlei Medical, Inc.

  • What is the regulatory classification of the Norapad devices?

    The Norapad devices are classified as class 2 devices with a regulation number of 882.4700.

  • What type of clearance do the Norapad devices have?

    The Norapad devices have been authorized with an FDA 510K clearance.