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)

U-CLIP UNI-FIRE, MODEL M65

K-Number: K081082 · 2008-05-07

ApplicantMedtronic, Inc.
Decision Date2008-05-07
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

U-CLIP UNI-FIRE, MODEL M65 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2008-05-07 under 510(k) number K081082. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-CLIP UNI-FIRE, MODEL M65?

U-CLIP UNI-FIRE, MODEL M65 is a medical device that received FDA 510(k) clearance on 2008-05-07. The listed applicant is Medtronic, Inc.. The 510(k) number is K081082.

When did U-CLIP UNI-FIRE, MODEL M65 receive FDA 510(k) clearance?

U-CLIP UNI-FIRE, MODEL M65 received FDA 510(k) clearance on 2008-05-07, under 510(k) number K081082.

Who is the listed applicant for U-CLIP UNI-FIRE, MODEL M65?

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

What is the FDA product code for U-CLIP UNI-FIRE, MODEL M65?

The FDA product code for U-CLIP UNI-FIRE, MODEL M65 is FZP.

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

Other records listing Medtronic, Inc. as applicant

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.

K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemK262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)K262005Affera Integrated Mapping SystemK261335VitalFlow Set with Balance™ BiosurfaceK261866Concerto Versa™ Detachable CoilK260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

View all 182 devices →

Related Devices (Code: FZP)

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.

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

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.

↑