Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RENEW INSERT

K-Number: K122003 · 2012-10-26

ApplicantRenew Medical, Inc.
Decision Date2012-10-26
Product CodePBP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENEW INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Renew Medical, Inc.. It received FDA 510(k) clearance on 2012-10-26 under 510(k) number K122003. The device is classified under product code PBP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENEW INSERT?

RENEW INSERT is a medical device that received FDA 510(k) clearance on 2012-10-26. The listed applicant is Renew Medical, Inc.. The 510(k) number is K122003.

When did RENEW INSERT receive FDA 510(k) clearance?

RENEW INSERT received FDA 510(k) clearance on 2012-10-26, under 510(k) number K122003.

Who is the listed applicant for RENEW INSERT?

The FDA 510(k) record lists Renew Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENEW INSERT?

The FDA product code for RENEW INSERT is PBP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: PBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243367Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)Minnesota Medical Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑