FDA 510(k)

IBAG

K-Number: K110518 · 2011-06-24

Decision Date2011-06-24

Product CodeKNX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

IBAG is the device name listed in this FDA 510(k) record. The listed applicant is Future Path Medical, LLC. It received FDA 510(k) clearance on 2011-06-24 under 510(k) number K110518. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBAG?

IBAG is a medical device that received FDA 510(k) clearance on 2011-06-24. The listed applicant is Future Path Medical, LLC. The 510(k) number is K110518.

When did IBAG receive FDA 510(k) clearance?

IBAG received FDA 510(k) clearance on 2011-06-24, under 510(k) number K110518.

Who is the listed applicant for IBAG?

The FDA 510(k) record lists Future Path Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IBAG?

The FDA product code for IBAG is KNX.

Related Devices (Code: KNX)

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.

K9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/S K972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.K964690LIBERTY VALVECleveland Medical Devices, 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.