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FDA 510(k)

TUBALGATOR

K-Number: K113080 · 2012-06-29

ApplicantMectra Labs, Inc.
Decision Date2012-06-29
Product CodeHIN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TUBALGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mectra Labs, Inc.. It received FDA 510(k) clearance on 2012-06-29 under 510(k) number K113080. The device is classified under product code HIN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBALGATOR?

TUBALGATOR is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Mectra Labs, Inc.. The 510(k) number is K113080.

When did TUBALGATOR receive FDA 510(k) clearance?

TUBALGATOR received FDA 510(k) clearance on 2012-06-29, under 510(k) number K113080.

Who is the listed applicant for TUBALGATOR?

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

What is the FDA product code for TUBALGATOR?

The FDA product code for TUBALGATOR is HIN.

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Other records listing Mectra Labs, Inc. as applicant

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Related Devices (Code: HIN)

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

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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