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FDA 510(k)

IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)

K-Number: K102325 · 2010-10-13

ApplicantCovidien, LLC, Formerly Registered AS Tyco Healthca
Decision Date2010-10-13
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC, Formerly Registered AS Tyco Healthca. It received FDA 510(k) clearance on 2010-10-13 under 510(k) number K102325. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)?

IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) is a medical device that received FDA 510(k) clearance on 2010-10-13. The listed applicant is Covidien, LLC, Formerly Registered AS Tyco Healthca. The 510(k) number is K102325.

When did IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) receive FDA 510(k) clearance?

IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) received FDA 510(k) clearance on 2010-10-13, under 510(k) number K102325.

Who is the listed applicant for IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)?

The FDA 510(k) record lists Covidien, LLC, Formerly Registered AS Tyco Healthca as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)?

The FDA product code for IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) is GDW.

Related Clinical Trials

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Other records listing Covidien, LLC, Formerly Registered AS Tyco Healthca 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.

K102605MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER

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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.

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Official Source

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