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FDA 510(k)

X-VOID, SPIDER

K-Number: K072198 · 2008-06-06

ApplicantSintea Biotech, Inc.
Decision Date2008-06-06
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-VOID, SPIDER is the device name listed in this FDA 510(k) record. The listed applicant is Sintea Biotech, Inc.. It received FDA 510(k) clearance on 2008-06-06 under 510(k) number K072198. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-VOID, SPIDER?

X-VOID, SPIDER is a medical device that received FDA 510(k) clearance on 2008-06-06. The listed applicant is Sintea Biotech, Inc.. The 510(k) number is K072198.

When did X-VOID, SPIDER receive FDA 510(k) clearance?

X-VOID, SPIDER received FDA 510(k) clearance on 2008-06-06, under 510(k) number K072198.

Who is the listed applicant for X-VOID, SPIDER?

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

What is the FDA product code for X-VOID, SPIDER?

The FDA product code for X-VOID, SPIDER is HRX.

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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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