510 K Medical Devices

Search the Releasable 510(k) Database | FDA

https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database

You can search the releasable 510 (k) database by Panel, 510 (k) number, Product code or Device name. A search query will produce information from the database in the following format: SUMMARY ...

Content of a 510(k) | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k

Premarket Notification 510(k) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

The device is made outside the U.S. and you are an importer of the foreign made medical device. A 510(k) is not required if a 510(k) has been submitted by the …

510(k) Submission Process | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process

Starting October 1, 2023, all 510(k) submissions, unless exempted (as described in Section VI.A of the final guidance, Electronic Submission Template for …

510(k) Devices Cleared in 2022 | FDA

https://www.fda.gov/medical-devices/510k-clearances/510k-devices-cleared-2022

This page lists all medical devices cleared through the CDRH Premarket Notification process [510 (K)] in 2022. January 2022 510 (K) Clearances. February 2022 510 (K) …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

Most class I and some class II devices are exempt from 510 (k) requirements, subject to certain limitations (see section 510 (l) (1) of the Federal Food, …

510(k) Frequently Asked Questions | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-frequently-asked-questions

No, the manufacture should submit the 510 (k), if required for the device. As required under 21 CFR 801.1 (c), where a device is not manufactured by the person whose name …

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&ProductCode=FTL&KNumber=&Applicant=ATRIUM%20MEDICAL%20CORPORATION&DeviceName=&Type=&ClinicalTrials=&DecisionDateTo=02%2F18%2F2023&Redact510K=&CombinationProducts=&ZNumber=&sortcolumn=kn_asc

510(k) Premarket Notification. ... Medical Devices; Databases - 1 to 3 of 3 Results ProductCode: FTL Applicant: ATRIUM MEDICAL CORPORATION Decision Date To: …

Medical Device Exemptions 510(k) and GMP Requirements

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/315.cfm

Following is a breakdown of 510 (k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510 …