510k Medical Device

510(k) Clearances | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This...

Premarket Notification 510(k) | FDA

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

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

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 …

510(k) Submission Process | FDA

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

After the Acknowledgement Letter is sent, the FDA routes the 510 (k) to the appropriate OHT, based on the device type and medical specialty that is listed in the 510 …

Device 510(k) Overview - Food and Drug Administration

https://open.fda.gov/apis/device/510k/

A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not …

510(k) Devices Cleared in 2023 | FDA

https://cacmap.fda.gov/medical-devices/510k-clearances/510k-devices-cleared-2023

510 (k) Devices Cleared in 2023 | FDA Home Medical Devices Products and Medical Procedures Device Approvals, Denials and Clearances 510 (k) Clearances 510 (k) Devices Cleared in...

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

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

510 (k) Statement or Summary Truthful and Accuracy Statement Proposed Labeling Specifications Substantial Equivalence Comparison Performance Additional …

510(k) Premarket Notification

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

510(k) Premarket Notification ... Medical Devices; Databases - 1 to 8 of 8 Results ProductCode: IZI Applicant: SHIMADZU MEDICAL SYSTEMS Decision Date To: …

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

A device may be exempt from 510 (k) requirements if the FDA determines that a 510 (k) is not required to provide reasonable assurance of safety and effectiveness …