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FDA 510(k)

MEDIGROUP KEY TUBE

K-Number: K013017 · 2001-12-06

ApplicantJanin Group, Inc.
Decision Date2001-12-06
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDIGROUP KEY TUBE 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 2001-12-06 under 510(k) number K013017. 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 MEDIGROUP KEY TUBE?

MEDIGROUP KEY TUBE is a medical device that received FDA 510(k) clearance on 2001-12-06. The listed applicant is Janin Group, Inc.. The 510(k) number is K013017.

When did MEDIGROUP KEY TUBE receive FDA 510(k) clearance?

MEDIGROUP KEY TUBE received FDA 510(k) clearance on 2001-12-06, under 510(k) number K013017.

Who is the listed applicant for MEDIGROUP KEY TUBE?

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 MEDIGROUP KEY TUBE?

The FDA product code for MEDIGROUP KEY TUBE is FJS.

Related Clinical Trials

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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 KITK991042ASH ADVANTAGE PERITONEAL CATHETERK970159FLEX-NECK PD 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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