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)

PC-204 TUNNELOR

K-Number: K823331 · 1983-01-26

ApplicantMedigroup
Decision Date1983-01-26
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PC-204 TUNNELOR is the device name listed in this FDA 510(k) record. The listed applicant is Medigroup. It received FDA 510(k) clearance on 1983-01-26 under 510(k) number K823331. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PC-204 TUNNELOR?

PC-204 TUNNELOR is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Medigroup. The 510(k) number is K823331.

When did PC-204 TUNNELOR receive FDA 510(k) clearance?

PC-204 TUNNELOR received FDA 510(k) clearance on 1983-01-26, under 510(k) number K823331.

Who is the listed applicant for PC-204 TUNNELOR?

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

What is the FDA product code for PC-204 TUNNELOR?

The FDA product code for PC-204 TUNNELOR is FKX.

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 Medigroup 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.

K823294MEDIGROUP LS-110 LIGHT SOURCEK823295MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&K823297ST-610 NEEDLESCOPE STERILIZATION TRAYK823293MEDIGROUP LG-102 LIGHT GUIDEK823390PC 201A LOCKING SLEEVEK823303QUILL CATHETER GUIDE

View all 9 devices →

Related Devices (Code: FKX)

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.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath

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.

↑