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FDA 510(k)

FALLER STYLET

K-Number: K130441 · 2013-04-19

ApplicantMedionics International, Inc.
Decision Date2013-04-19
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FALLER STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Medionics International, Inc.. It received FDA 510(k) clearance on 2013-04-19 under 510(k) number K130441. 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 FALLER STYLET?

FALLER STYLET is a medical device that received FDA 510(k) clearance on 2013-04-19. The listed applicant is Medionics International, Inc.. The 510(k) number is K130441.

When did FALLER STYLET receive FDA 510(k) clearance?

FALLER STYLET received FDA 510(k) clearance on 2013-04-19, under 510(k) number K130441.

Who is the listed applicant for FALLER STYLET?

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

What is the FDA product code for FALLER STYLET?

The FDA product code for FALLER STYLET is FJS.

Related Clinical Trials

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Other records listing Medionics International, 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.

K993149PERITONEAL DIALYSIS CATHETERS AND ADAPTERSK994218EASY CARE AND TUBING SETSK945567QC CAP

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, LLCK121383PS 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.K071167FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560Medigroup, 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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