FDA 510(k)

ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452

K-Number: K022198 · 2003-03-21

ApplicantRichard Wolf Medical Instruments Corp.

Decision Date2003-03-21

Product CodeGWG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K022198. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452?

ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K022198.

When did ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 receive FDA 510(k) clearance?

ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 received FDA 510(k) clearance on 2003-03-21, under 510(k) number K022198.

Who is the listed applicant for ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452?

The FDA product code for ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 is GWG.

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 Richard Wolf Medical Instruments Corp. as applicant

K151282core nova Complete Operating Room Endoscopy K130423THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 K120898KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA K090776MEGAPULSE LASER SYSTEM AND FIBERS K080617POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES

View all 142 devices →

Related Devices (Code: GWG)

K253602Precision S 4K SinuscopeStryker Endoscopy K253679Hydro Irrigation SystemStryker Instruments K243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences Corporation K233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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.