FDA 510(k)

ULTRACLIP II MR

K-Number: K041201 · 2004-06-03

ApplicantInrad

Decision Date2004-06-03

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ULTRACLIP II MR is the device name listed in this FDA 510(k) record. The listed applicant is Inrad. It received FDA 510(k) clearance on 2004-06-03 under 510(k) number K041201. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACLIP II MR?

ULTRACLIP II MR is a medical device that received FDA 510(k) clearance on 2004-06-03. The listed applicant is Inrad. The 510(k) number is K041201.

When did ULTRACLIP II MR receive FDA 510(k) clearance?

ULTRACLIP II MR received FDA 510(k) clearance on 2004-06-03, under 510(k) number K041201.

Who is the listed applicant for ULTRACLIP II MR?

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

What is the FDA product code for ULTRACLIP II MR?

The FDA product code for ULTRACLIP II MR is GDW.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Inrad as applicant

K093399PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 K093256SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 K090611REVOLUTION FULL CORE BIOPSY K063238ULTRACLIP II WING AND ULTRACLIP II COIL K042341ULTRACLIP II US K000612ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE

View all 11 devices →

Related Devices (Code: GDW)

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.