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FDA 510(k)

Freezpoint

K-Number: K180211 · 2018-03-21

ApplicantBovie Medical Corp.
Decision Date2018-03-21
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Freezpoint is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corp.. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K180211. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freezpoint?

Freezpoint is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Bovie Medical Corp.. The 510(k) number is K180211.

When did Freezpoint receive FDA 510(k) clearance?

Freezpoint received FDA 510(k) clearance on 2018-03-21, under 510(k) number K180211.

Who is the listed applicant for Freezpoint?

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

What is the FDA product code for Freezpoint?

The FDA product code for Freezpoint is GEH.

Other records listing Bovie Medical Corp. as applicant

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.

K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpiecesK170777Bovie J-Plasma Precise FLEX HandpieceK170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical GeneratorK161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-AspiratingK161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical GeneratorK152777Bovie Disposable Bipolar Ablator

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Related Devices (Code: GEH)

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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