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FDA 510(k)

FALLER TROCAR

K-Number: K120130 · 2012-05-21

ApplicantMedigroup, Inc.
Decision Date2012-05-21
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FALLER TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Medigroup, Inc.. It received FDA 510(k) clearance on 2012-05-21 under 510(k) number K120130. 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 TROCAR?

FALLER TROCAR is a medical device that received FDA 510(k) clearance on 2012-05-21. The listed applicant is Medigroup, Inc.. The 510(k) number is K120130.

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

FALLER TROCAR received FDA 510(k) clearance on 2012-05-21, under 510(k) number K120130.

Who is the listed applicant for FALLER TROCAR?

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

What is the FDA product code for FALLER TROCAR?

The FDA product code for FALLER TROCAR is FJS.

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Other records listing Medigroup, 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.

K071167FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560K070730FLEX-NECK ARC CATHETERK060897EMBEDDING TOOL, MODEL TE-1000K031351FLEX-NECK PD CATHETER, INFANTK974570PERITONEAL DIALYSIS CATHETER CONNECTOR

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.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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