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FDA 510(k)

ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP

K-Number: K130059 · 2013-07-29

ApplicantIbi Israel Biomedical Innovations , Ltd.
Decision Date2013-07-29
Product CodePBQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP is the device name listed in this FDA 510(k) record. The listed applicant is Ibi Israel Biomedical Innovations , Ltd.. It received FDA 510(k) clearance on 2013-07-29 under 510(k) number K130059. The device is classified under product code PBQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP?

ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP is a medical device that received FDA 510(k) clearance on 2013-07-29. The listed applicant is Ibi Israel Biomedical Innovations , Ltd.. The 510(k) number is K130059.

When did ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP receive FDA 510(k) clearance?

ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP received FDA 510(k) clearance on 2013-07-29, under 510(k) number K130059.

Who is the listed applicant for ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP?

The FDA 510(k) record lists Ibi Israel Biomedical Innovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP?

The FDA product code for ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP is PBQ.

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Related Devices (Code: PBQ)

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

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