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FDA 510(k)

BOVIE MODEL X15

K-Number: K972161 · 1997-06-18

ApplicantMaxxim Medical
Decision Date1997-06-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOVIE MODEL X15 is the device name listed in this FDA 510(k) record. The listed applicant is Maxxim Medical. It received FDA 510(k) clearance on 1997-06-18 under 510(k) number K972161. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOVIE MODEL X15?

BOVIE MODEL X15 is a medical device that received FDA 510(k) clearance on 1997-06-18. The listed applicant is Maxxim Medical. The 510(k) number is K972161.

When did BOVIE MODEL X15 receive FDA 510(k) clearance?

BOVIE MODEL X15 received FDA 510(k) clearance on 1997-06-18, under 510(k) number K972161.

Who is the listed applicant for BOVIE MODEL X15?

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

What is the FDA product code for BOVIE MODEL X15?

The FDA product code for BOVIE MODEL X15 is GEI.

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Related Devices (Code: GEI)

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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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