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)

OPTIUM DBM GEL AND PUTTY

K-Number: K053098 · 2005-11-28

ApplicantLifenet
Decision Date2005-11-28
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTIUM DBM GEL AND PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Lifenet. It received FDA 510(k) clearance on 2005-11-28 under 510(k) number K053098. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIUM DBM GEL AND PUTTY?

OPTIUM DBM GEL AND PUTTY is a medical device that received FDA 510(k) clearance on 2005-11-28. The listed applicant is Lifenet. The 510(k) number is K053098.

When did OPTIUM DBM GEL AND PUTTY receive FDA 510(k) clearance?

OPTIUM DBM GEL AND PUTTY received FDA 510(k) clearance on 2005-11-28, under 510(k) number K053098.

Who is the listed applicant for OPTIUM DBM GEL AND PUTTY?

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

What is the FDA product code for OPTIUM DBM GEL AND PUTTY?

The FDA product code for OPTIUM DBM GEL AND PUTTY is MBP.

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: MBP)

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.

K242799PliaFX FloLifenet HealthK130703VIVORTE BVFVivorte, Inc.K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.K122513CLEARED UNDER GRAFTON II EDBMMedtronic Sofamor Danek, Inc.K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHans Biomed Corp.K103742ACCELL EVO3 (FORMERLY ACCELL A2I)Integra Life Sciences

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.

↑