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FDA 510(k)

SurgeoBite

K-Number: K172978 · 2017-12-22

ApplicantSurgovations, LLC
Decision Date2017-12-22
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SurgeoBite is the device name listed in this FDA 510(k) record. The listed applicant is Surgovations, LLC. It received FDA 510(k) clearance on 2017-12-22 under 510(k) number K172978. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgeoBite?

SurgeoBite is a medical device that received FDA 510(k) clearance on 2017-12-22. The listed applicant is Surgovations, LLC. The 510(k) number is K172978.

When did SurgeoBite receive FDA 510(k) clearance?

SurgeoBite received FDA 510(k) clearance on 2017-12-22, under 510(k) number K172978.

Who is the listed applicant for SurgeoBite?

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

What is the FDA product code for SurgeoBite?

The FDA product code for SurgeoBite is JXL.

Related Devices (Code: JXL)

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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