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FDA 510(k)

FLEX-NECK PD CATHETER

K-Number: K970159 · 1997-09-05

ApplicantJanin Group, Inc.
Decision Date1997-09-05
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEX-NECK PD CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Janin Group, Inc.. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K970159. The device is classified under product code FJS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX-NECK PD CATHETER?

FLEX-NECK PD CATHETER is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Janin Group, Inc.. The 510(k) number is K970159.

When did FLEX-NECK PD CATHETER receive FDA 510(k) clearance?

FLEX-NECK PD CATHETER received FDA 510(k) clearance on 1997-09-05, under 510(k) number K970159.

Who is the listed applicant for FLEX-NECK PD CATHETER?

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

What is the FDA product code for FLEX-NECK PD CATHETER?

The FDA product code for FLEX-NECK PD CATHETER is FJS.

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 Janin Group, 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.

K012502MEDIGROUP CATHETER EXTENDER/REPAIR KITK013017MEDIGROUP KEY TUBEK991042ASH ADVANTAGE PERITONEAL CATHETERK810512MEDISEAL CAMERA COVERS

Related Devices (Code: FJS)

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.

K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, LLCK180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderCovidien, LLCK130441FALLER STYLETMedionics International, Inc.K121383PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)Medical Components, Inc.K120130FALLER TROCARMedigroup, Inc.K113354VETA PERITONEAL DIALYSIS CATHETERPfm Medical, Inc.

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.

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