Skip to content

Noodle

by Pourang Bral, Dds, LLC

510(k) K220573

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 NumberK220573 Date9 Jul 2022ClearedStatusActive

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  • Withdrawn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
NUH
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

Noodle is a device classified under product code NUH, which corresponds to a neurology-related device type as indicated by the advisory committee description. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.

The device was manufactured by Pourang Bral, DDS, LLC located at 155 Albion St., Passaic, NJ 07055. It received FDA 510(k) clearance under K220573 on July 9, 2022, following submission on February 28, 2022. No further details regarding sterility, single-use status, MRI safety, sizes, storage, or clinical indications are provided in the data.

Other devices from Pourang Bral, Dds, LLC

  • Noodle

    Class II

Questions

AI-generated answers, 19 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 Noodle device intended for?

    The Noodle device is classified under product code NUH, which corresponds to a neurology-related device type as indicated by the advisory committee description. However, the provided data does not specify clinical indications or intended use beyond this classification, so no further details about its intended medical purpose can be derived from the information given.

  • How was the Noodle device cleared for market?

    The Noodle device received FDA 510(k) clearance through a traditional submission process. It was determined to be substantially equivalent to a predicate device, as indicated by the decision code SESE and decision description 'Substantially Equivalent', following its submission on February 28, 2022, and clearance on July 9, 2022, under K220573.

  • Who manufactures the Noodle device and where is it made?

    The Noodle device is manufactured by Pourang Bral, DDS, LLC, located at 155 Albion St., Passaic, NJ 07055, United States. This information is explicitly stated in the manufacturer and address fields of the device data.

  • Is the Noodle device sterile or designed for single-use?

    The provided device data does not include any information regarding the sterility status or single-use versus reusable design of the Noodle device. These details are not specified in the specifications, description, or any other field within the given data.

  • What sizes or models are available for the Noodle device?

    The device data does not provide any information about available sizes, models, or variations of the Noodle device. No specifications related to dimensions, configurations, or model numbers are included in the provided details.